Pill delivery device

Abstract

A device for dispensing one or more medicaments in the form of pellets is provided. The device comprises a cartridge assembly configured to store the medicaments in the form of pellets and to dispense the medicaments upon actuation of one or more dispensing mechanisms located within the cartridge assembly. The device further comprises a control unit configured to actuate one or more dispensing mechanisms located within the cartridge assembly; and a lid comprising a collection area configured to receive and store the medicaments dispensed from the one or more dispensing mechanisms. The lid is movable between a first position in which a closed cavity is formed in the collection area of the lid and a second position in which the collection area is exposed so that a user can access the medicaments contained therein.

Description

Technical Field

[0001] The present disclosure generally relates to pill delivery devices and various aspects of such devices, such as aspects related to dispensing pills from the device, the operation and mechanics of such devices, and the control systems of such devices. Background Art

[0002] Oral dosage form ("ODF") drugs can be made in the form of, for example, tablets or pills. Tablets or pills can contain different substances, the main component of which is the active pharmaceutical ingredient ("API"). Pills can be administered to patients in the form of pre-filled capsules or compressed in tablets with the help of a filling material. Dispensing mechanisms for various forms of ODF drugs are known and can range from blister-pack type devices to dispensing bottles, in the case of blister-pack type devices, where individual tablets can be retained in cavities and retained therein by using a foil. Also known are various more complex mechanisms, especially for other types of pharmaceutical formulations, such as those in the form of pills, which typically can be less than 10% of a specific dose per unit. The advantage of dispensing drugs in the form of pills is that the same dispensing device can be used to vary the dose. Another advantage is that pills can be easily swallowed by patients with difficulty swallowing, who currently crush tablets in order to swallow them. Nowadays, patients also crush or split tablets to obtain, for example, half a dose from prescription drugs, which is a non-recommended process, and this process can be avoided if the device can dispense different flexible amounts of pills. The variable dosing of pills can more precisely adjust the dose compared to what can be achieved with larger dosage forms such as tablets or capsules. In addition, for modified release formulations, pills are generally more robust to food interactions than larger dosage forms such as tablets.

[0003] It is desirable to improve the dispensing mechanism for drugs in the form of pills, for example, in the case of pediatric drugs; in geriatrics, antibiotics are easy to swallow; in the case of certain controlled substances such as stimulants for ADHD or pain medications (e.g., opioids), chronic drugs are easy to swallow; to improve the control of the dispensed dose or to limit overdose or for drugs that require titration or flexible adjustment at the start due to disease variability or having achieved the desired outcome.

[0004] It is also desirable to improve the user's control when handling the dose of one or more drugs in the form of pills, especially when they are received from the dispensing device, for example, to deliver the full dose to the user (e.g., to a suitable receptacle or food) in a safe manner and suitable for swallowing.

[0005] It is also desirable to improve the user's control of the dispensing device while ensuring that the device can prevent the user from changing the dose (e.g., overdose) or accessing the drug contained in the device undesirably. For example, it is desirable to increase the tamper resistance of a pellet drug dispenser, e.g., by ensuring that the user's access is limited to a prescribed dose. Summary of the Invention

[0006] Accordingly, various aspects and embodiments of a device for dispensing one or more drugs in pellet form will be described. The features described in this overview can be combined with any aspect and embodiment of the invention described herein, so long as they are suitable therefor. It will be understood that all of the devices described herein operate on similar principles.

[0007] According to one aspect of the invention, there is provided a device for dispensing one or more drugs in pellet form, which comprises a cartridge assembly, a control unit, and a lid. The cartridge assembly is configured to store the drug in pellet form and to dispense the drug upon actuation of one or more dispensing mechanisms located within the cartridge assembly. The control unit is configured to actuate one or more dispensing mechanisms located within the cartridge assembly. The lid includes a collection area configured to receive and store the drug dispensed from the one or more dispensing mechanisms and is movable between a first position and a second position, in which first position the collection area of the lid forms a closed cavity and in which second position the collection area is exposed so that the user can access the drug contained therein.

[0008] The above features, particularly the use of a lid that is movable between a first position and a second position to enclose and then expose the collection area, provide a drug delivery device that can more reliably and safely dispense drugs in pellet form. Such drugs, which may be referred to as oral dosage forms as described herein, may be in the form of pellets, which optionally have a diameter between about 150 μm and about 1200 μm (e.g., between about 300 μm and about 900 μm), further optionally between about 500 μm and about 700 μm, and are generally very difficult to handle, and as described in further detail herein, the above device results in various advantages for handling and dispensing this type of drug.

[0009] The drug may be referred to as an oral dosage form and may be a unit dose and / or a solid oral dosage form. It is contemplated that in some cases, the oral dosage form may include a hard, solid (or semi-solid, e.g., gelatin or cellulose) outer shell and a softer core, such as a gel or even a liquid core.

[0010] The device may form a handheld device for dispensing one or more drugs in pellet form. Such a device may be an improvement over the types of devices for dispensing pellet-type drugs, especially when combined with features that allow the device to safely and reliably dispense such drugs.

[0011] The device and / or apparatus can be a hand-held and / or portable device and / or apparatus. In other words, the apparatus can be held and transported with one hand and / or be operable with one hand.

[0012] For example, the length (corresponding to its longest dimension) of the assembled device and / or apparatus can be no greater than about 250 mm (e.g., less than about 200 mm, about 150 mm, or about 100 mm), and the width or height (i.e., transverse to its length) can be no greater than about 50 mm, and optionally no greater than about 40 mm (and in some embodiments less than 30 mm or even less than 20 mm).

[0013] To optimize its hand-held nature, the length of the assembled device and / or apparatus can be between about 150 mm and about 220 mm (e.g., about 160 mm to about 180 mm, and optionally about 165 mm), the width (perpendicular to its length) can be between about 35 mm and about 45 mm (optionally about 40 mm), and the height (transverse to its width) can be between about 22 mm and about 32 mm (optionally about 28 mm).

[0014] The weight of the assembled device and / or apparatus can be no more than about 500 g, about 400 g, about 300 g, about 200 g, or even about 100 g. This can ensure that the assembled device and / or apparatus is light enough to be carried with one hand.

[0015] The length (corresponding to its longest dimension) of the cartridge (or cartridge assembly) can be between about 90 mm and about 120 mm (optionally about 105 mm), the width (transverse to its length) can be between about 33 mm and about 43 mm (optionally about 40 mm), and the height (transverse to its width) can be between about 15 mm and about 32 mm, e.g., between about 23 mm and about 32 mm (optionally about 28 mm).

[0016] The enclosed chamber can be formed by the lid and a portion of the cartridge assembly and the control unit.

[0017] The device can be configured such that when the lid occupies its first position, the drug received in the collection area from one or more dispensing mechanisms is securely held within the collection area. In other words, when the lid occupies its first position, the drug received in the collection area cannot escape therefrom.

[0018] The second position of the lid can be a position where the lid is separated (e.g., completely separated) from the rest of the device, such as from a cartridge, a cartridge assembly, and / or a control unit. This allows for increased versatility. For example, the user can reduce the chance of dose spillage and take the dose directly into their mouth. Additionally, it is easier to pour or dispense pellets from a separated lid than from a lid that is still attached to the device. In these and other embodiments, the lid can be referred to as a cap, such as a detachable cap.

[0019] The cap or lid can be connected to the rest of the device, such as a cartridge, a cartridge assembly, and / or a control unit, by a snap fit, which provides a convenient way to disassemble and reattach the cap or lid. Alternatively, the cap or lid can be connected to the rest of the device, such as a cartridge, a cartridge assembly, and / or a control unit, by an interference fit, a magnetic latch, a clip fastener, or a screw connection. The cap or lid can be connected to the cartridge, the cartridge assembly, or the control unit such that the outer surface of the cap or lid is flush with the rest of the outer surface of the device.

[0020] The cap or lid can include a tactile area or surface. The tactile area or surface can be located in the area of the cap or lid that is most likely to be grasped by the user, such as adjacent to the edge of the cap or lid that is configured to contact the rest of the device. Alternatively, the tactile area or surface can include a portion of the cap or lid that corresponds to the upper or lower surface of the device. The tactile area or surface can be provided as one or more of cavities, pits, protrusions, and ridges.

[0021] The cap or lid can have a flat base that extends to an upper edge via a curved side surface (e.g., the cap or lid can be cup-shaped and / or in the form of a cup). The curved side surface can be configured such that when placed on the curved side surface, the cap or lid automatically moves to its position where it rests on the base, such as when pellets are contained in the collection area. The cap or lid can be weighted (e.g., the base) to ensure that the cap or lid is constructed in this way (although weighting is not necessary).

[0022] The device can include a funnel, which can be provided in place of or in addition to the cap or lid. The funnel can include an inlet end that is configured to be placed on the outlet end of the cartridge assembly and / or the dispensing mechanism to receive the pellets dispensed therefrom. The funnel can include an outlet end that is configured to receive the pellets dispensed from the dispensing mechanism of the cartridge assembly and guide the pellets to a collection area.

[0023] If the funnel is provided in place of the lid, the collection area mentioned above will be formed by the internal volume of the funnel, which can include an outlet end that is configured to dispense the pellets from the funnel into a receptacle (e.g., the user's hand).

[0024] In embodiments where a funnel is provided in addition to a cap or lid, the outlet end of the funnel can be at least partially positioned within the collection area of the cap or lid. In this way, the funnel can be configured to direct the pellets from the dispensing mechanism into the collection area.

[0025] The outlet end of the funnel can be offset or otherwise positioned so that the pellets are directed to a particular portion of the collection area. For example, the outlet end of the funnel can be positioned adjacent to and / or covering a particular portion of the collection area. The particular portion can be a corner of the cap, a central area of the cap, or a smaller cavity configured to receive a certain dose of pellets. The funnel can be configured such that the pellets are directed into the bottom corner of the cap that is on the same side as the lower surface of the device. For example, the outlet end of the funnel can be positioned adjacent to and / or covering the corner corresponding to the lower surface of the device.

[0026] The funnel can include one or more screens extending across the outlet end of the funnel, and the one or more screens can be configured to capture the pellets dispensed from the dispensing mechanism of the cartridge assembly and temporarily hold them before dispensing them into the collection area. The screen can be provided as a grille that includes a plurality of bars configured to capture the pellets dispensed from the dispensing mechanism of the cartridge assembly and then temporarily hold (e.g., slow down) the pellets before further dispensing the pellets from the funnel into the collection area.

[0027] The one or more screens can be configured such that the pellets are more likely to fall through the screen in a first dispensing direction and less likely to fall through the screen in a second non-dispensing direction. For example, if the screen is a grille, the bars of the grille can be teardrop-shaped, e.g., including a curved edge opposite a sharp edge, where the sharp edge faces the dispensing mechanism of the cartridge assembly.

[0028] The cap or lid can include an insert or solid portion configured to direct the pellets to a portion or the particular portion of the collection area. The insert or solid portion can include a tapered surface configured such that in use, when the pellets are dispensed from the dispensing mechanism, the pellets flow along the surface to the particular portion of the collection area.

[0029] One or more dispensing mechanisms can be configured to store the drug in the form of pellets and, when actuated, move one or more pellets of the drug from one or more storage cavities within the cartridge assembly to the collection area of the lid.

[0030] Each of the one or more dispensing mechanisms can include one or more rotatable elements, and rotation of the one or more rotatable elements moves the drug from a respective one of the various storage cavities within the cartridge assembly to the collection area of the lid.

[0031] One or more rotatable elements may include a screw pump, which may be configured as a positive displacement pump (“PD”) that uses one or several screws to move the medicament in the form of pellets along the (one or more) screw axes from the storage chamber to the collection area of the lid.

[0032] The lid may slide relative to the cartridge assembly and the control unit and between its first position and its second position. This provides a relatively easy way to move the lid between its first and second positions. As described above, in other embodiments, the lid may be detachable.

[0033] In various embodiments, the collection area of the lid may take the form of an open, substantially U-shaped trough and / or a cup, and may include one or more pouring lips at its upper edge, which are configured to pour the medicament in the form of pellets out of the collection area when the lid is in its second position.

[0034] One or more pouring lips may be formed at one or more corners of the upper edge to provide a highly focused way to dispense the pellets from the collection area.

[0035] Additionally or alternatively, one or more pouring lips may be formed between the corners of the upper edge, where the wall portion of the trough or cup between the corners bulges at least partially (e.g., bulges in a direction away from the collection area) to provide the pouring lips. This will give the user a quick indication of the location of the pouring lips.

[0036] As described above, the collection area of the lid may take the form of a generally U-shaped trough, and the lid may further include a plate that partially encloses the collection area when the lid is moved to its second position, and wherein the plate includes one or more holes that are configured to dispense the medicament in the form of pellets from the collection area when the lid occupies its second position.

[0037] According to one aspect of the invention, there is provided a method of using the device as described above, comprising:

[0038] Actuating at least one dispensing mechanism to dispense a dose of one or more medicaments into the collection area, wherein when the lid is in its first position, the one or more medicaments are received and stored in the collection area; and then

[0039] Moving the lid from its first position to its second position to expose the collection area and the dose of one or more medicaments contained therein.

[0040] In any of the aspects and embodiments described herein, one or more dispensing mechanisms may each include one or more rotatable elements, and rotation of the one or more rotatable elements may cause pellets / drugs to move from corresponding storage cavities within the cartridge assembly to a collection area of the lid, wherein the cartridge assembly may include one or more locking members movable between a first position and a second position, wherein each of the locking members is configured to prevent actuation of the corresponding dispensing mechanism in the first position and to allow actuation of the dispensing mechanism in the second position.

[0041] A single locking member may be provided that is movable between a first position and a second position, wherein the single locking member is configured to prevent actuation of a plurality of dispensing mechanisms in the first position and to allow actuation of the dispensing mechanisms in the second position. This may simplify the assembly and / or reduce the number of parts required.

[0042] One or more locking members may slide between their first position and their second position.

[0043] These features are considered advantageous in themselves. Thus, according to one aspect of the invention, which may be claimed independently, there is provided a device for dispensing one or more drugs in the form of pellets, the device comprising:

[0044] a cartridge assembly configured to store a drug in the form of pellets and to dispense the drug upon actuation of one or more dispensing mechanisms located within the cartridge assembly;

[0045] a control unit including one or more actuators configured to actuate one or more dispensing mechanisms located within the cartridge assembly,

[0046] wherein each of the one or more dispensing mechanisms includes one or more rotatable elements, and rotation of the one or more rotatable elements causes the drug to move from a respective one of the respective storage cavities within the cartridge assembly to a collection area of the lid.

[0047] wherein the cartridge assembly includes one or more locking members movable between a first position and a second position, wherein the locking members are each configured to prevent actuation of the corresponding dispensing mechanism in the first position and to allow actuation of the dispensing mechanism in the second position.

[0048] Using one or more locking members as described above means that actuation of the dispensing mechanisms within the cartridge can be prevented when the locking members occupy the first position and is only allowed when the locking members move to their second position. This has been found to improve the tamper - proof characteristics of a device for dispensing drugs in the form of pellets, e.g., the diameter of the drug is optionally between about 150 μm and about 1200 μm (e.g., about 300 μm to about 900 μm), further optionally between about 500 μm and about 700 μm.

[0049] The following optional features can be combined with any aspect or embodiment of the present invention that includes a locking member.

[0050] One or more locking members can be configured to prevent rotation of a corresponding rotatable element when the locking member occupies its first locked position. This provides a convenient and effective way to prevent actuation of the dispensing mechanism.

[0051] The cartridge assembly can be configured to dock with and separate from the control unit, and the device can be configured such that when the cartridge assembly docks with the control unit, each locking member moves from its first locked position to its second unlocked position.

[0052] The locking members can each include one or more pins configured to contact one or more stationary portions of the control unit, wherein contact between the pins and the stationary portions causes the locking member to move from its first locked position to its second unlocked position when the cartridge assembly docks with the control unit.

[0053] The rotatable element can include one or more radially extending surfaces, and the locking member can include one or more teeth configured to engage the radially extending surfaces when the locking member occupies its first locked position and to disengage from the radially extending surfaces when the locking member is in its second unlocked position.

[0054] The rotational movement of the locking member can be restricted so as to prevent rotation of the rotatable element when the locking member occupies its first locked position and the teeth engage the radially extending surfaces, and to allow rotation of the rotatable element when the locking member occupies its second unlocked position and the teeth disengage from the radially extending surfaces.

[0055] The locking members can be biased toward their first locked positions by one or more respective elastic members such that the teeth are biased by the elastic members to engage the radially extending surfaces.

[0056] One or more actuators can each include an electric motor configured to rotate a corresponding one of the rotatable elements.

[0057] The cartridge assembly can include one or more rotatable connection elements, each rotatable connection element being connected to a corresponding one of the rotatable elements and configured to cooperate with a rotatable connection element on the control unit such that rotation of the connection element on the control unit causes rotation of the connection element on the cartridge assembly to rotate the rotatable element of the dispensing mechanism on the cartridge assembly.

[0058] One of the connection elements on the cartridge assembly and the control unit can include a male connector, while the other connection element on the cartridge assembly and the control unit can include a matching female connector.

[0059] The connecting element on the control unit may include a male connector, while the connecting element on the cartridge assembly may include a mating female connector.

[0060] The connector may include a star-shaped, cross-shaped or square connector.

[0061] As an alternative to the embodiments involving male and female connecting elements, a spline connection may be provided between the cartridge assembly and the control unit, as cooperating splines are provided on the control unit and the cartridge assembly, which cooperate with each other when the cartridge assembly and the control unit are engaged. In these embodiments, the engagement of the splines means that the rotation of the splines associated with the control unit causes the rotation of the splines on the cartridge assembly, thereby rotating the rotatable element of the dispensing mechanism on the cartridge assembly.

[0062] In an improvement of these embodiments (including the spline connection), the radially extending surface mentioned above may be formed by the radially extending surface of the splines associated with the cartridge assembly. This can reduce the number of parts required to provide the engagement mechanism and the locking mechanism, as the splines associated with the cartridge assembly contribute to the operation of both mechanisms.

[0063] According to one aspect of the present invention, a method of using the device as described above is provided.

[0064] The method can include storing pellets providing an oral dosage form in a cartridge assembly (e.g., its cartridge), where the pellets can include a drug or compound for treating one or more of the following diseases: attention deficit hyperactivity disorder (“ADHD”—where the drug or compound can include amphetamine and / or methylphenidate), systemic pain (where the drug or compound can include one or more of fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocodone, oxycodone, hydromorphone, naltrexone, buprenorphine, and methadone), immunosuppression after organ transplantation (where the drug or compound can include one or more of tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate mofetil, and azathioprine), diabetes (where the drug or compound can include one or more of sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, dapagliflozin, empagliflozin, and semaglutide), heart failure (where the drug or compound can include one or more of carvedilol, metoprolol, bisoprolol, and diuretics), Parkinson's disease (“PD”—where the drug or compound may include levodopa and / or carbidopa), epilepsy (where the drug or compound can include one or more of sodium valproate, sodium carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, etosimide, and topiramate), depression (where the drug or compound can include one or more of citalopram, bupropion, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine, and reboxetine), schizophrenia (where the drug or compound can include one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, and olanzapine), cancer, animal health.

[0065] The method can include using the device to treat one or more of the following diseases: attention deficit hyperactivity disorder (“ADHD”), systemic pain, immunosuppression after organ transplantation, diabetes, heart failure, Parkinson's disease (“PD”), epilepsy, depression, schizophrenia, cancer, and animal health. When used in a specific treatment, the oral dosage form within the cartridge assembly (e.g., its cartridge) can include one or more of the drugs or compounds mentioned above for that specific treatment.

[0066] The method can include moving one or more locking members from their first position to their second position to allow actuation of one or more dispensing mechanisms located within the cartridge assembly.

[0067] In any of the above aspects or embodiments, the cartridge assembly can be configured to dock with the control unit to connect one or more dispensing mechanisms with one or more actuators located within the control unit to permit operation of the one or more dispensing mechanisms and dispense medication from the device, and to disconnect from the control unit to disconnect the one or more dispensing mechanisms from the one or more actuators located within the control unit to prevent dispensing of medication from the device.

[0068] This feature is considered advantageous in itself. Thus, according to one aspect of the invention which may be claimed independently, there is provided a device for dispensing one or more medications in the form of pellets, the device comprising:

[0069] a cartridge assembly configured to store medication in the form of pellets and to dispense the medication upon actuation of one or more dispensing mechanisms located within the cartridge assembly;

[0070] a control unit comprising one or more actuators configured to actuate one or more dispensing mechanisms located within the cartridge assembly,

[0071] wherein the cartridge assembly is configured to dock with the control unit to connect one or more dispensing mechanisms with one or more actuators located within the control unit to permit operation of the one or more dispensing mechanisms and dispense medication from the device, and to disconnect from the control unit to disconnect the one or more dispensing mechanisms from the one or more actuators located within the control unit to prevent dispensing of medication from the device.

[0072] Further technical effects will become apparent from the description provided below.

[0073] Definitions

[0074] The definitions referred to below relate to features of the invention described and claimed herein and may be incorporated into the description (e.g., claims) where appropriate.

[0075] Pellets - individual granules or microparticles (e.g., drugs, pharmaceuticals, medicaments, etc.) of an oral dosage form, having a diameter optionally between about 150 μm and about 1200 μm or 1500 μm (e.g., between about 300 μm and about 900 μm), optionally between about 500 μm and about 700 μm. In various embodiments, the size (e.g., the maximum size, width or diameter) of the pellets can be in one or more of the following ranges: 150 - 300 μm; 150 - 400 μm; 200 - 400 μm; 200 - 500 μm; 300 - 500 μm; 400 - 600 μm; 300 - 700 μm; 500 - 700 μm; 200 - 800 μm; 600 - 800 μm; 700 - 900 μm; 700 - 1200 μm; 800 - 1000 μm; 800 - 1100 μm; 900 - 1100 μm; 900 - 1200 μm; and 1000 - 1200 μm. "Diameter" means that although the pellets can be irregularly shaped, they are assumed to be approximately spherical. If not considered spherical, the diameter can correspond to the maximum width of the pellets. The pellets may or may not have a surface coating. The general term for pellet - type drugs can be "microparticles".

[0076] Dose – a single measurement of the pellets, e.g., a total of about 0.05 ml to about 0.8 ml by volume (e.g., about 0.1 ml to about 0.6 ml), e.g., about 0.3 ml by volume.

[0077] Dispensing mechanism – a system, e.g., an electromechanical system, that converts the user's action into dose dispensing.

[0078] Cartridge - a user - replaceable system for storing and dispensing pellets.

[0079] Dispensing aperture – the output end of the cartridge that allows the dispensing of pellets for ingestion.

[0080] Cap - a container that covers the dispensing aperture, for collecting and providing the dose, and protecting the stored pellets and the components of the cartridge from moisture. In some embodiments, the cap can take the form of a cap that can be completely removed from the rest of the dispensing mechanism. Alternatively, the cap can be a sliding lid that remains attached to the dispensing mechanism during normal use. BRIEF DESCRIPTION OF THE DRAWINGS

[0081] The various embodiments will now be described only by way of example and with reference to the accompanying drawings, in which:

[0082] Figure 1 A perspective view of an apparatus or device according to various aspects and embodiments of the present invention is shown;

[0083] Figure 2 Shown separately Figure 1 is the control unit of theFigure 2A A close-up view of the control unit is shown;

[0084] Figure 3 As shown Figure 2 A similar perspective view of the device is shown, but with the cartridge assembly of the device, which includes a cartridge and a lid that thus cooperates with the control unit;

[0085] Figure 4 The cartridge and the control unit without the lid are shown, while Figure 3 and Figure 4A a cartridge moving in a direction away from the interface of the control unit (i.e., in the detachment direction) is shown, and Figure 4B a separate lid is shown;

[0086] Figure 5 The device when the lid is moved to the second position is shown, while Figure 5A how the lid moves to expose the collection area of the lid is shown;

[0087] Figure 6 An embodiment is shown in which the lid includes a plate that partially encloses the collection area when the lid is moved to its second position;

[0088] Figure 7 The cartridge assembly is shown in a position where the cartridge is connected to the control unit and fixed and / or locked in place relative to the control unit, while Figure 7A a locking tab that can move with the body of the cartridge is shown;

[0089] Figure 8 A cross-sectional view of the assembly in its assembled state is shown, while Figure 8A is shown Figure 8 an enlarged view of

[0090] Figure 9 A perspective view of the assembly in a partially disassembled state is shown, where the cartridge assembly is shown approaching but not engaging the control unit, Figure 9A A close-up view of the cartridge in sliding engagement with the control unit before docking with the control unit is shown;

[0091] Figure 10 and 10A are shown Figure 9 and 9A views of an assembly similar to

[0092] Figure 11 A cross-section of the device is shown, while Figure 11A a close-up where the locking plate of the cartridge can be seen in more detail is shown, andFigure 11B Shows a separate actuator assembly locking plate and a rotating member;

[0093] Figure 12A -D shows a housing including a rotating cylinder that can be used in combination with or in place of a lid;

[0094] Figure 13A -C shows a funnel that can be used as an alternative to a lid;

[0095] Figure 14 Shows in relation to Figure 1 A device similar to the device shown, where the same elements are denoted by the same reference numerals, but having a cap or lid that can be detached (e.g., completely) from the rest of the device;

[0096] Figure 15 Shows Figure 14 An exploded view of the device;

[0097] Figure 16 Shows Figure 14 The device, where the cap is partially cut away;

[0098] Figure 17 Shows an embodiment of a cap for use in Figure 14 The device, which includes a plurality of features that facilitate the targeted pouring of pellets;

[0099] Figure 18 And Figure 19 Show an embodiment of a cap that includes one or more inserts or solid portions configured to direct pellets to a specific part of the cap;

[0100] Figure 20A And 20B Show another embodiment of a cap including a solid portion or insert;

[0101] Figure 21 Shows Figure 14 A side view of the device, while Figure 21A Shows a cross-section of the lower end of Figure 14 The device in its assembled state;

[0102] Figure 22 And 22A Show an embodiment of a lid for use with Figure 14 The device, which includes a tactile area or surface.

[0103] Figure 23 、 23A 、24, 24A, 25 and 26 show various embodiments of the tactile surface with respect to Figure 22 And 22A As described;

[0104] Figure 27A and Figure 27B shows an embodiment of a funnel for use with a device of Figure 14 ;

[0105] Figure 28 shows embodiments of funnels of 27A and 27B having a screen in the form of a grille for controlling the release of pellets from the funnel;

[0106] Figure 29A -D show various embodiments of the screen, which include Figure 28 alternatives to the grille of

[0107] Figure 30 and 30A shows embodiments similar to the embodiments discussed above with respect to Figures 9 to 11 but having a slightly different mechanism for operating the dispensing mechanism of the cartridge;

[0108] Figure 31A and Figure 31B shows in more detail the mechanism of Figure 30 and 30A ;

[0109] Figure 32A shows a perspective view of an alternative locking member relative to that shown in Figure 30 and 30A and a side view of the locking member of Figure 32B shows Figure 32A ; Detailed Description

[0110] Figure 1 shows a perspective view of a device or apparatus 10 according to various aspects and embodiments of the present invention and forms a drug delivery device capable of dispensing one or more drugs in the form of pellets. The purpose of the device 10 is to make the dispensing of repeat prescriptions simpler and more convenient than, for example, existing blister-packaged drugs, and to be able to change the administered dose in a straightforward manner if a certain treatment is desired (e.g., for those drugs that would benefit from infusion or flexible adjustment). The device 10 also aims to improve the user's control when handling doses of one or more drugs in pellet form and to improve the user's control of the dispensing device while ensuring that the device can prevent the user from changing the dose (e.g., overdose).

[0111] In various embodiments, the device 10 can deliver a dose that meets regulatory standards, such as within + / - 10% of the desired dose, or even within + / - 5% of the desired dose.

[0112] Figure 1Shows the device or apparatus 10 in an assembled state, where the device 10 includes a control unit 100 and a cartridge assembly 200. The cartridge assembly 200 is configured to cooperate with the control unit 100 such that the control unit 100 can operate the cartridge assembly 200 to dispense one or more doses of a drug, preferably in the form of pellets.

[0113] In the illustrated embodiment, the device 10 is generally oval in shape, having a generally flat upper surface 12 and a curved lower surface 14 opposite the upper surface 12. Although this shape is visually appealing, the device 10 is not limited to this particular arrangement and can provide other suitable shapes while achieving the functions described herein. The device extends from a first end 22 to an opposite second end 22.

[0114] Figure 1 The illustrated control unit 100 includes the entire upper surface 12 of the device 10. The control unit 100 can further include an input device or user interface 102 and a display 104, both of which can be located on the upper surface 12 of the device 10 and at the second end 22, although in various embodiments they can be located at other suitable positions on the control unit 100.

[0115] The device 10 is configured as a handheld unit and is appropriately sized. For example, the device 10 can be easily rested in the user's palm, and the user interface 102 can be operated by the user's thumb in a manner similar to a remote control device. The dimensions of the device 10 can be no more than approximately 200 mm, 150 mm, or 100 mm in length and / or width. For example, the maximum dimension of the device 10 can be between approximately 50 mm and approximately 200 mm, such as approximately 100 mm to about 200 mm, or about 100 mm to about 150 mm.

[0116] The device 10 can also be light enough such that the user can easily carry and operate it with one hand. In various embodiments, the device 10 (including the control unit 100 and the cartridge assembly 200) can have a weight of approximately 200 g to 500 g, such as 300 g to 400 g. The weight of the device 10 can be no more than 400 g.

[0117] Figure 2 The control unit 100 is shown independently and a perspective view shows a portion of the control unit that forms the lower surface 14 of the device 10.

[0118] The control unit 100 extends from the first end 20 to the second end 22 of the device 10 (when assembled) such that the first end 20 and the second end 22 are also opposite ends of the control unit 100.

[0119] The control unit 100 is divided into a first portion 110 facing the first end 20 and a second portion 120 facing the second end 22. The first portion 110 is configured to receive and accommodate the cartridge assembly 200, while the second portion 120 is configured to contain various control electronics and actuators for controlling the dispensing of one or more drugs from the cartridge assembly 200. The device 10 may include a battery, and the battery may be accommodated within the first portion 110. This may help to evenly distribute the weight of the device 10 and make it more comfortable to hold and / or easier to operate.

[0120] The control unit 100 may include an interface 130 at the junction between the first portion 110 and the second portion 120, which is configured to mate and cooperate with various mechanical and electrical features located on the cartridge assembly 200 (to be described in more detail hereinafter).

[0121] The first portion 110 and the second portion 120 of the control unit 100 may occupy approximately equal halves of the control unit 100, wherein the junction between the first portion 110 and the second portion 120 may extend across the lateral centerline of the control unit 100.

[0122] The first portion 110 includes a generally planar portion 112 extending from the junction between the first portion 110 and the second portion 120 to the first end 20 of the control unit 100.

[0123] The first portion 110 further includes two opposing walls 114, which extend at least partially along either side of the control unit 100. The walls 114 may extend from the junction between the first portion 110 and the second portion 120 towards the first end 20 of the control unit 100, but may terminate before reaching the first end 20. The outer surfaces of the walls 114 may form the outer surface of the device 10. As Figure 2A shown in more detail, the first portion 110 of the control unit 100 further includes two tracks 116 (although any suitable location on the control unit 100 may be used) that may extend along the upper surfaces of the walls 114, and the tracks 116 are configured to guide the cartridge assembly 200 onto the control unit 100.

[0124] The second portion 120 of the control unit 100 includes various electronics and other components for operating / controlling the cartridge assembly 200 and the user interface. When assembled, the outer surface of the second portion 120 may form the outer surface of the device 10, such as its lower surface 14. The second portion 120 may include an input port 122 located towards the second end 22 of the control unit 100, and the input port 122 may receive power and electronic control inputs via a suitable input device such as a computer.

[0125] Figure 3shows a perspective view similar to Figure 2 , but the cartridge assembly 200 of the device 10 is mated with the control unit 100.

[0126] The cartridge assembly 200 includes a cartridge 202 and a lid 204 slidable relative to the cartridge 202. The cartridge assembly 200 including the cartridge 202 and the lid 204 is configured to slide onto a first portion 110 of the control unit 100 to engage with the control unit 100. When the cartridge assembly 200 engages with the control unit 100, the cartridge 202 can be substantially fixed in place while the lid 204 can slide relative to the cartridge.

[0127] The cartridge 202 and / or the lid 204 can be made of a material selected from the following: vectran, liquid crystal polymer, polybutylene terephthalate (“PBT”), acrylonitrile butadiene styrene (“ABS”), polypropylene (“PP”), polycarbonate (“PC”). In various embodiments, the cartridge 202 and / or the lid 204 can be made of stainless steel or aluminum. In embodiments where the lid 204 is transparent, the lid 204 can be made of an amorphous and / or semi-crystalline polymer, such as polycarbonate (“PC”), polypropylene (“PP”), styrene acrylonitrile resin (“SAN”), polyethylene terephthalate (“PET”).

[0128] Figure 4 Shows the cartridge 202 and the control unit 100 without the lid 204. The cartridge 202 can be configured to dispense one or more drugs and can be controlled by the control unit 100. In various embodiments, the cartridge 202 includes one or more dispensing mechanisms 300 that are housed within a housing 240 and are configured to be actuated by the control unit 100. The one or more dispensing mechanisms 300 can include one or more rotatable elements (described in more detail below) such that a rotary drive within the control unit 100 can rotate the one or more rotatable elements of the cartridge 202 to move one or more drugs, such as in the form of pellets, out of the cartridge 202 and dispense them from respective outlet ends 302 of each dispensing mechanism 300.

[0129] Various suitable mechanisms in this regard are described in International (PCT) Patent Publication No. WO 2019 / 115832, which is incorporated herein by reference in its entirety. For example, one or more dispensing mechanisms can include a screw pump 306 actuated (e.g., rotated) by the control unit 100 (e.g., see Figure 21A ), such that the screw pump 306 is configured to move one or more drugs, such as in the form of pellets, from one or more storage cavities within the cartridge 202 for dispensing from the cartridge 202.

[0130] The cartridge 202 includes one or more first guiding cavities 242 formed in the housing 240 and configured to receive cooperating tracks 216 (described below) on the lid 204 to assist in guiding the lid 204 onto the cartridge 202 to form the cartridge assembly 200. In the illustrated embodiment, two sets of three first guiding cavities 244 are provided, each set located on either side of the cartridge 200 (to cooperate with the tracks 216 on the lid 204). However, any suitable number of first guiding cavities 242 and cooperating tracks 216 may be provided according to various embodiments.

[0131] Figure 4A The cartridge 202 is shown moving in a direction away from the interface 130 of the control unit 100 (i.e., the detachment direction), and one or more second guiding cavities 244 are shown provided on the outer surface of the housing 240 and configured to straddle along tracks 116 on the control unit 100 to guide the cartridge 202 (and the cartridge assembly 200) onto the control unit 100. In the illustrated embodiment, two identical second guiding cavities 244 are provided on either side of the cartridge 200 (to cooperate with two identical tracks 116 on the control unit 100). However, any suitable number of second guiding cavities 244 and cooperating tracks 116 may be provided according to various embodiments. For example, a single guiding rail may be provided that extends along the planar portion 112 in the engagement direction, which obviates the need for cavities on the sides of the cartridge. The guiding rails described herein may include a dovetail cross-section to assist in guiding the cartridge assembly 200 onto the control unit 100.

[0132] The outlet end 302 of the dispensing mechanism 300 is located at (or adjacent to) the first dispensing end 250 of the cartridge 202. The cartridge 202 further includes one or more features on its second mating end 252 (see, for example Figure 9A ) that are configured to mate and cooperate with features of the control unit 100 at the interface 130. This mating will be described in more detail below.

[0133] Figure 4B The isolated lid 204 is shown and can be seen to have a generally U-shaped cross-section such that when the lid 204 engages the surface of the control unit, the lid 204 is placed flush with the surface of the control unit 100.

[0134] The lid 204 includes a generally concave inner surface 210 and a generally convex outer surface 214, where the outer surface 214 may correspond to the curved lower surface 14 of the device 10 in its assembled state. The inner surface 210 includes a plurality of protrusions or tracks 216 that are configured to cooperate with one or more first guiding cavities 242 on the cartridge 202 (e.g., see Figure 4)Collaboration (such as assembly) to assist in guiding the lid 204 onto the cartridge 202. The track 216 is configured to allow the lid 204 to slide relative to the longitudinal axis of the cartridge 202 while preventing other movement or detachment of the lid 204 and the cartridge 202 (e.g., lateral movement relative to the longitudinal axis of the cartridge 202).

[0135] Referring Figure 4 and Figure 4B , the first guiding cavity 242 and the track 216 on the lid 204 allow the lid 204 to slide a limited amount relative to the cartridge 202. That is, one or more walls 243 are provided between the guiding cavities 242 and are located on their longitudinal axes (e.g., coincident therewith), and the walls 243 serve as stoppers for the respective tracks 216 on the lid 204 during the relative sliding of the lid 204 and the cartridge 200.

[0136] To initially assemble the lid 204 onto the cartridge 202 (to form the cartridge assembly 200), it will be necessary to deform the lid 204 so that the tracks 216 can move over the walls 243 and into their respective guiding cavities 242. Once the tracks 216 are positioned within their respective guiding cavities 242, they cannot be removed unless the lid 204 is plastically deformed again. However, depending on the lengths of the guiding cavities 242 and the tracks 216, the lid 204 is capable of sliding a limited amount relative to the cartridge 202.

[0137] Now referring Figure 4B , the lid 204 extends from a first end 220 to a second end 222, where the first end 220 is configured to be substantially coincident with the first end 20 of the device 10, and the second end 222 is configured to contact a portion of the outer surface 14 of the control unit 100 at its interface 130 when the device 10 is in its assembled state, as Figure 1 shown.

[0138] The cartridge assembly 200 is configured such that the pellets dispensed from the cartridge 202 are collected within a portion of the lid 204 near its first end 220 so that they are not lost and can be easily accessed by the user. The lid 204 includes a plate or baffle 218 that is located a distance X from the first end 220 and extends laterally (relative to the longitudinal axis of the lid 204). The distance X can be between approximately 10 mm and 20 mm, such as between 11 mm and 14 mm.

[0139] In the illustrated embodiment, the cartridge 202 includes two dispensing mechanisms 300, each configured to dispense a drug in the form of pellets and including an outlet end 302 disposed on a portion of the baffle 218. According to various aspects, the device 10 is configured such that one or more drugs dispensed from the dispensing mechanism 300 will fall into the collection area 230 of the lid 204. For example, this means that the user can more easily control the dispensing and subsequent handling of one or more drugs. In various embodiments, more than two dispensing mechanisms 300 may be provided, or a single dispensing mechanism 300 may be provided.

[0140] Another function of the lid 204 is to accommodate the pellets when they are discharged from the dispensing mechanism 300 of the cartridge 202. For example, upon leaving the dispensing mechanism 300, the pellets may have a significant amount of energy (e.g., the dispensing method may impart a significant amount of kinetic energy to the pellets), and thus the pellets may be prone to, for example, bouncing off a relative surface (if the lid 204 were not present).

[0141] When the device 10 is in its assembled state (e.g., as Figure 1 shown), the collection area 230 of the lid 204 forms an enclosed cavity. In this way, any drug dispensed into the collection area 230 in this state is retained by the device 10 and is not lost to the environment.

[0142] To access one or more drugs contained in the cartridge 202, the user can move the lid 204 from its first position as Figure 1 shown to a second position (see Figure 3 ). As Figure 5 shown, when the lid 204 is moved to the second position, the first end 220 of the lid 204 moves away from the first end 20 of the control unit 100, which exposes the collection area 230 of the lid 204 and allows access to the drugs contained therein.

[0143] Referring again to Figure 4B , the lid 204 includes means for accurately pouring one or more drugs from the collection area 230 into a suitable receptacle (e.g., a glass, cup, or spoon), particularly when the one or more drugs are in pellet form. For this purpose, the lid 204, particularly its collection area 230, includes one or more pouring lips 226 configured to accurately dispense pellet-type drugs into, for example, a receptacle. In the illustrated embodiment, two pouring lips 226 are provided, formed by the rounded corners of the lid 204, which also form the corners of the device 10 in the Figure 1 shown assembled state. Although this is considered to be a visually appealing and also convenient arrangement, other types of pouring lips may be provided. For example, a single pouring lip may be provided.

[0144] Figure 5A Shows how the lid 204 is moved out from below the upper surface 12 of the device 10 and the control unit 100 to expose the collection area 230 of the lid 204 and the pouring lips 226 located on either side of the lid 204.

[0145] In the assembled state of the device 10 (e.g., as Figure 1 shown), and when the lid 204 is in its first position, the collection area 230 is a closed cavity such that drugs cannot be dispensed from the device 10. When the lid 204 is moved to its second position, as Figure 3 , 5 and 5A show, the collection area 230 is exposed such that one or more drugs contained therein can be accessed and / or dispensed from the device 10. In various embodiments, the device 10 (e.g., its control unit 100) may include a sensor configured to detect whether the lid 204 is in its first and / or second position.

[0146] Figure 6 Shows an alternative embodiment where the lid 204 includes a plate 212 that partially encloses the collection area 230 when the lid 204 is moved to its second position. The plate 212 includes holes 227 that are configured to allow one or more drugs contained within the collection area 230 to pass therethrough and be dispensed into, for example, a suitable receptacle. The size of the holes 227 may be suitable for one or more drugs in the form of pellets. For example, the holes 227 may have a maximum width of less than about 20 mm, such as 15 mm (e.g., for any dimension of the holes 227). Additionally or alternatively, the maximum width of the holes 227 (e.g., for any dimension of the holes 227) may be at least twice the width (e.g., average width) of the pellets contained within the cartridge 200, such as between about 300 μm and about 3 mm.

[0147] In the illustrated embodiment, the holes 227 are teardrop-shaped, which easily guides the pellets from the collection area 230. However, other shapes are possible, such as circular, square, etc. This embodiment may allow enhanced tamper resistance as it will limit user access to the collection tray 230, particularly the output end of the cartridge cylinder.

[0148] Thus, as described above, various embodiments of the device 10 are described that include a lid 204 configured to collect and dispense pellets during a drug administration operation. Once the drug administration operation is completed (e.g., once the cartridge 202 has dispensed one or more doses of one or more drugs), the user can slide the lid 204 outwards to expose the collection area 230. This allows one or more drugs, particularly drugs in the form of pellets, to be poured from the device 10 into, for example, a suitable receptacle or compatible food in a controlled manner.

[0149] When the lid 204 is in its first closed or engaged position (as Figure 1 shown), access to the collection area 230 is prevented, which also provides improved shielding for the outlet of the cartridge 202 to help protect the cartridge 202 from a hostile environment (such as ingress of moisture). The user can slide the lid 204 open to a second dispensing position with one or both hands (see, for example, Figure 5 and 5A ), and in various embodiments, haptic feedback can be provided, for example, by stoppers in the form of protrusions and cavities on the lid 204 and the control unit 100 or the cartridge 202.

[0150] The user can dispense one or more drugs under the operation of the control unit 100 so as to dispense the drugs in the form of pellets from the cartridge 202 into the collection area 230. The pellets are then held in the collection area and are at least partially prevented from leaving by the baffle 218, which is configured to follow the contours of the cartridge housing 240 and / or the dispensing mechanism 300 and helps to provide an enclosed cavity for the collection area 230 when the lid 204 is in its first position.

[0151] As described above, in one embodiment (for example, see Figure 6 ), the lid 204 is provided such that when the lid 204 is moved to the second dispensing position, an opening as wide as the device 10 itself is formed. This provides a simple mechanism in which two opposite corners of the lid 204 can form pouring lips 226 from which the user can pour the pellets, for example, using the left or right hand.

[0152] In another embodiment, as described above with reference to Figure 6 , the lid 204 includes a plate 212 formed from a flat plate that extends across the width of the lid 204, in which holes 227 are provided such that one or more drugs can be poured out from a single centralized point. In this embodiment, one or more internal ribs 229 can be provided to guide the drugs (such as pellets) held in the collection area 230 to the holes 227 to help ensure that all the drugs contained in the collection area 230 are poured out of the device 10. Additionally, and as described above, the small holes 227 allow enhanced tamper resistance by restricting access to the collection area 230. The size of the holes 227 can vary with the size of the drug (such as the pellets contained within the cartridge assembly 200). The relationship between the width (such as the average width) or diameter of the drug (such as pellets) and the width of the hole can be at least 1:1, and in various embodiments, the width of the holes 227 can be between 1 and 1.5 times the width (such as the average width or diameter) of the pellets. The internal ribs 229 that help to guide the drugs must also be greater than the angle of repose of the pellets.

[0153] In various embodiments, the lid 204 can be replaced by other features that perform similar functions.

[0154] For example, in various embodiments as shown in FIGS. 12A - D, the lid 204 can be replaced by a housing 400 that includes a rotatable cylinder 404. The housing 400 can include an inlet end 405 that is configured to be placed above the outlet end of the cartridge 202 in order to receive one or more medicaments therefrom. The pellets will be dispensed from the cartridge 202 into a collection area 430 of the housing 400 in a manner similar to the collection area 230 of the lid 204 described above. The collection area 430 of the housing 400 forms an enclosed chamber defined by the housing 400, the rotatable cylinder 404, and the cartridge 202, and can be sealed from the exterior of the device 10. The cylinder 404 includes a circumferential notch 407 that has a volume corresponding to the desired dose of medicament. When the user is ready to dispense one or more medicaments contained in the circumferential notch 407, they can rotate the cylinder 404. Then, the circumferential notch 407 moves about the axis of rotation of the cylinder 404 and pushes the pellets into an outlet end 406 of the housing 400 that is located on the side of the housing 400 opposite the collection area 430. Then, the pellets fall from the housing 400 onto, for example, a suitable receptacle.

[0155] Although not shown currently in Figure 12A -D, it is believed that those skilled in the art will understand how to incorporate the rotatable cylinder 404 and its housing 400 into the device 10 as described above and herein. For example, the device 10 can be modified such that the housing 400 (schematically shown only in Figure 12A -D) can be attached to the cartridge 202 in place of the lid 204 by any suitable means. In various embodiments, it is contemplated that the housing 400 and the rotatable cylinder 404 can be combined with the lid 204. For example, the rotatable cylinder 404 can be placed between the dispensing mechanism 300 of the cartridge 202 such that the user can rotate the rotatable cylinder 404 and pour the pellets into the collection area of the lid 204 (e.g., similar to the collection area 230). It will be appreciated that in such embodiments, the length of the device 10 (and the collection area of the lid) will have to be increased to accommodate the rotatable cylinder 404 and the housing 400.

[0156] In as Figure 13AIn various embodiments shown in -C, the lid 204 can be replaced by a funnel 500. The funnel 500 includes an inlet end 505 that is configured to be placed above the outlet end of the cartridge 202 to receive one or more medicaments therefrom. Thus, the funnel 500 can be configured to receive one or more medicaments in its collection area 530 in the same manner as the collection area 230 of the lid 204 described above. However, the collection area 530 of the funnel 500 may not form an enclosed cavity but may allow the user to directly dispense the medicament in the form of pellets onto, for example, a suitable receptacle or food. The funnel 500 may include features (e.g., one or more baffles or plates 507 located within the collection area 530) to prevent a clear line of sight to the outlet end of the cartridge 202, which can increase the tamper resistance of the device 10 including the funnel 500. The funnel 500 may additionally or alternatively include a flexible plate (not shown) that includes holes at its outlet 502.

[0157] Similar to Figure 12A the embodiment of the rotating barrel 404 in -D, it will be appreciated that in Figure 13A the depiction of the funnel 500 in -C is schematic, and those skilled in the art will understand how to incorporate the funnel 500 into the device 10 as described above and herein.

[0158] Now referring to Figure 7 and Figure 7A , a cartridge assembly 200 including a cartridge 202 and a lid 204 and a control unit 100 are shown.

[0159] Figure 7 The cartridge assembly 200 is shown in a position where the cartridge 202 is connected to the control unit 100 and fixed and / or locked in place relative to the control unit 100. That is, user input is required to unlock the cartridge 202 and the cartridge assembly 200 from the control unit 100. Additionally, the lid 204 of the cartridge assembly 200 is in its second dispensing position to show that the lid 204 is slidable relative to the cartridge assembly 200 when the cartridge 202 is locked in place relative to the control unit 100.

[0160] To lock the cartridge 202 in place with the control unit 100, a locking tab 260 is provided on the cartridge that is configured to engage (and disengage) with a feature of the control unit 100. The locking tab 260 is provided on the outer surface 270 of the cartridge housing 240 that is opposite the inner surface 110 of the lid 204. As Figure 7A shown, the locking tab 260 can move with the body of the cartridge 202 and is configured to slide under the lower surface 14 of the control unit 100 to lock the cartridge 202 in place.

[0161] At the rear of the lid 204, one or more tactile features (shown as three parallel recessed lines 228 in Figure 7A ) may be provided, configured to assist the user in sliding the lid between a first position and a second position. Additionally or alternatively, the lid 204 may include a rough texture, friction coating, etc. added to its outer surface 214 or thereon to increase the grip.

[0162] In various embodiments, the lid 204 may be made of a substantially rigid and durable material to help protect the cartridge 202 from physical damage and also increase tamper resistance. Additionally or alternatively (and as described below), the lid 204 may be made of a translucent and / or transparent material to allow the user to observe one or more drugs (e.g., pellets) deposited in the collection area 230 before moving the lid 204 to its second dispensing position.

[0163] Figure 8 A cross-sectional view of the assembly 10 in an assembled state is shown, where the lid 204 is in its first position. Figure 8A Shown Figure 8 is an enlarged view to show the mechanism by which the locking tab 260 engages and disengages with the control unit 100.

[0164] The control unit 100 includes an outer wall 140, the outer surface of which forms the lower surface 14 of the control unit 100. In the region of the interface 130, the outer wall 140 includes a recess or cavity 142 configured to mate with a flange or lip 262 of the locking tab 260. The flange or lip 262 may include a triangle such that when the cartridge 202 is moved into engagement with the control unit 100, the flange or lip 262 includes an inclined surface 265 that contacts the end face 144 of the outer wall 140, such that the inclined surface 265 rides along the end face 144 and forces the locking lug 260 downward to pass it through the end face 144 of the outer wall 140. The locking tab 260 is elastic such that when it reaches the notch or cavity 142, the flange or lip 262 will spring back into the notch or cavity 142. In this position (as Figure 8A shown), since the flange or lip 262 cannot move in the separation direction, the user cannot remove the cartridge 202 from the control unit 100 without pressing the locking tab 260.

[0165] The locking tab 260 may include a tactile feature 264 (a pop-up symbol in the illustrated embodiment), which is configured to prompt the user to press the locking tab 260 when it is desired to disengage the cartridge 202 and the cartridge assembly 200 from the control unit 100. By doing so, the flange or lip 262 moves downward and out of the recess or cavity 142, such that the cartridge 202 and the cartridge assembly 200 can slide away from the control unit 100.

[0166] The lid 204 also includes tactile features 228 (in the illustrated embodiment, three parallel lines or depressions) on its outer surface 214 and is adjacent to the locking tab 260 when the cartridge assembly 200 is engaged with the control unit 100. The tactile features 228 on the outer surface 214 of the lid 204 are configured to prompt the user to slide the lid 204 to its second dispensing position using this portion of the lid 204 so that the user can access one or more drugs contained in its collection area 230. Sliding the lid 204 to its second position in this manner also exposes the tactile feature 264 located on the locking tab 260 of the cartridge 202. In other words, before any drug is dispensed from the lid 204, the tactile feature 264 that prompts the user to press the locking tab 260 to disengage the cartridge 202 is hidden behind the lid 204. This reduces the chance of the cartridge 202 being accidentally ejected during dispensing.

[0167] In various embodiments, the lid 204 can be made of a transparent or translucent material such that when the lid 204 is in its first position, i.e., before moving the lid 204 to its second dispensing position, the user can see the drugs (e.g., pills) deposited in the collection area 230. This can reduce the chance of the user inadvertently opening the lid 204 and, for example, accidentally spilling some or all of the dose. Additionally or alternatively, the lid 204 can be a different color or marked differently from other parts of the device 10 (e.g., the cartridge 202 and / or the control unit 100) so that the user can easily distinguish and / or determine the function of the lid from the other parts 204 of the device 10.

[0168] Generally, as described above, the cartridge assembly 200 and the control unit 100 are configured to engage with each other to allow the control unit 100 to operate the cartridge mechanism to dispense the drugs contained within the cartridge 202. This engagement is initiated by inserting the cartridge assembly 200 into the first portion 110 of the control unit 100 (see Figure 2 ) such that the guiding cavity 244 on the cartridge 202 engages with the mating track 116 on the control unit 100 to allow the cartridge assembly 200 to slide along the planar portion 112 and towards the interface 130 of the control unit 100.

[0169] Figure 9 A perspective view of the assembly 10 in a partially disassembled state is shown, where the cartridge assembly 200 is shown approaching but not engaged with the control unit 100. Additionally, the lid 204 has also been slid back from the control unit 100 to expose the locking tab 260.

[0170] Figure 9AA close-up view of the cartridge 202 in sliding engagement with the control unit 100 prior to docking is shown, and various features located on the second mating end 250 of the cartridge 202 are shown, which are configured to mate with cooperating features at the interface 130 of the control unit 100.

[0171] The cartridge 202 includes one or more convex connecting elements 280, each of which forms part of a respective dispensing mechanism 300 located within the cartridge 202 as described above. The convex connecting elements 280 are located at the mating end 250 of the cartridge 202 and are received within a circular cavity 282 formed in the outer surface of the mating end 250 (although the cavity 282 need not be circular). Rotation of the convex connecting elements 280 can cause actuation of the respective dispensing mechanisms 300 such that one or more drugs, e.g., in the form of pellets, are dispensed from the cartridge 202 as the convex connecting elements 280 are rotated. In the illustrated embodiment, the convex connecting elements 280 are shown as star-shaped elements, although any suitable rotatable connecting element can be used.

[0172] The cartridge 202 also includes one or more movable pins 284, which form part of respective locking members or plates 290 (see Figure 11 and 11A ). The one or more movable pins 284 are located at the mating end 250 of the cartridge 202 and are retained within a cavity 286 formed in the outer surface of the mating end 250. The pins 284 are movable into the cavity 286 that receives them, the reason for which will become apparent based on the following description. In the illustrated embodiment, a total of 4 pins are provided, although any suitable number of pins can be used while still providing the functionality described herein. The pins 284 are shown as having a solid circular cross-section; however, the pins 284 can include other cross-sections to aid in the anti-tampering characteristics of the cartridge assembly 200, such as a hollow cylinder or a cross-shaped cross-section. If the pins have such a cross-section or other irregular cross-section, it may be more difficult to depress the pins, which can contribute to the anti-tampering characteristics of the cartridge.

[0173] Figure 10 and 10A A view similar to Figure 9 and 9A of the assembly 10 is shown, but the view is rotated so that the features of the interface 130 of the control unit 100 can be seen in more detail; the features are configured to mate with the features on the mating end 250 of the cartridge 202 shown in Figure 9 and 9A .

[0174] As Figure 10AAs shown, the interface 130 includes one or more concave connection elements 180, each of which is configured to mate with a corresponding convex connection element 280 located on the cartridge 202. The concave connection element 180 is configured to drive (e.g., rotate) the convex connection element 280 so as to cause actuation of the corresponding dispensing mechanism 300, as described above. The concave connection element 180 may be driven by one or more actuation mechanisms (e.g., one or more electric motors) located within the control unit 100. The concave connection element 180 may be surrounded by a corresponding cylindrical cover 182, which fits into and engages a circular cavity 282 of the cartridge 202. The fit between the cylindrical cover 182 and the circular cavity 282 may be a tight fit, but may not be a friction fit or an interference fit to avoid interference between the connection elements 180, 280.

[0175] Although the interface 130 is described as including concave connection elements and the cartridge 202 is described as including convex connection elements, in various embodiments, these may be switched such that the interface 130 includes convex connection elements and the cartridge 202 includes concave connection elements. It should be understood that the function of the connection elements on the interface 130 may remain the same, i.e., driving the connection elements on the cartridge and thereby driving the dispensing mechanism 300 within the cartridge 202. As shown, using convex connection elements on the cartridge may result in improved tamper resistance because it is generally more difficult to actuate a convex connection element without a corresponding concave connection element compared to the opposite case.

[0176] The interface 130 also includes one or more static pins 184, which are configured to abut a movable pin 284 of the cartridge 202 when the cartridge 202 engages the control unit 100. The one or more static pins 184 are configured to push the movable pin 284 in a direction away from the interface 130 when the cartridge 202 is moved into engagement with the control unit 100.

[0177] According to various aspects, the dispensing mechanism 300 within the cartridge 202 may be actuated only when the cartridge 202 engages the control unit 100. To achieve this, the movable pin 284 forms part of a corresponding locking plate 290 (as described above), which is configured to prevent actuation of the dispensing mechanism 300 in a first locked position and to allow actuation of the dispensing mechanism 300 in a second unlocked position.

[0178] Figure 11 A cross-section of the device 10 is shown, Figure 11A A close-up is shown where the locking plate 290 can be seen in more detail.

[0179] Referring Figure 11A , one or more convex connection elements 280 of the cartridge 202 are each connected to one or more components of a corresponding dispensing mechanism 300 (e.g.,Figure 11A the shaft 304 shown in FIG. such that rotation of the male connection element 280 causes actuation of the corresponding dispensing mechanism 300, whereby a defined dose of medicament can be dispensed from the device 10.

[0180] The locking element 290 is arranged substantially concentrically around the male connection element 280 and is biased by an elastic member 294 (e.g., a spring) in the direction towards the interface 130 of the control unit 100 when the cartridge 202 approaches the engagement position. The locking plate 290 is movable in a direction along the longitudinal axis Y of the connection element 280 (and optionally, the shaft 304), wherein the connection element 280 is configured to rotate about the longitudinal axis Y to actuate the dispensing mechanism 300 as described above.

[0181] Figure 11B Two male connection elements 280A, 280B and respective locking plates 290A, 290B are shown, which are isolated from the shafts 304A, 304B of their respective dispensing mechanisms, wherein for illustrative purposes, the first locking plate 290A is shown moved to the unlocked position and the second locking plate 290B is shown in its first locked position. Except for showing their positions, the first locking plate 290A is identical to the second locking plate 290B and both have the same structure as the locking plate 290 described above.

[0182] In its unlocked position, the first locking plate 290A exposes one or more radially extending portions 286 of the male connection element 280A, which define a circumferential cavity 287 therebetween. The radially extending portions 286 may include surfaces that extend radially and axially relative to the rotational axis of the corresponding shaft 304. The locking plates 290A, 290B include one or more teeth 292, which are configured to enter the respective cavity 287 in the locked position and move out of their respective cavity 287 in the unlocked position. The teeth 292 may extend circumferentially relative to the rotational axis of the corresponding shaft 304.

[0183] The locking plates 290A, 290B are each restricted in rotational movement, which means that in the locked position (as shown by the second locking plate 290B), the male connection element 280B cannot rotate due to the engagement of the teeth 292 within their respective cavities 287. In contrast, in the unlocked position (as shown by the first locking plate 290A), the male connection element 280A can rotate freely due to the circumferential teeth 292 disengaging from their respective cavities 287. That is, in the locked position, the teeth 292 of the locking plate 290 can occupy the same circumferential plane as the radially extending portions 286 relative to the rotational axis of the corresponding shaft 304, thereby preventing rotation of the corresponding shaft 304, and then as the locking plate 290 moves to its unlocked position, the teeth 292 move out of the same circumferential plane to allow rotation of the corresponding shaft 304.

[0184] To operate the component 10, a user can slide the cartridge assembly 200 into the control unit 100, during which they will experience minimal resistance until the interface of the cartridge assembly 200 contacts the cooperating interface of the control unit 100. At this time, the pin 284 on the cartridge assembly 200 contacts the mating pin 184 on the control unit 100, which begins to move the locking plate 290 from its first locked position to its second unlocked position. Before any interaction between the interfaces of the cartridge assembly 200 and the control unit 100, as described above, the locking plate 290 prevents the rotation of the shaft 304 and the actuation of the dispensing mechanism 300. Once the interfaces of the cartridge assembly 200 and the control unit 100 are connected and the cartridge assembly 200 is fully docked with the control unit 100, the locking plates 290 move to their second unlocked position, which allows the rotation of the shaft 304 and the actuation of the dispensing mechanism 300.

[0185] The device 10 may include one or more features configured to latch the cartridge assembly 200 to the control unit 100 and prevent relative movement between the cartridge assembly 200 and the control unit 100 when it is fully docked thereon. For example, locking tabs 260 ( Figure 8A ) may be provided on the cartridge assembly 200 that grip mating notches or cavities 142 within the control unit 100. The force of the elastic members 294 may bias the cartridge assembly 200 in a direction away from the interface 130 of the control unit 100 to minimize relative movement between the cartridge assembly 200 and the control unit 100. These features may also help to hold the cartridge assembly 200 firmly in place.

[0186] A user can eject the cartridge assembly 200 by pulling the lid 204 backward to expose the locking tab 260 (such as the pop-up button thereon). The user can then push down on the locking tab 260, causing it to bend downward and allowing the cartridge assembly 200 to slide relative to the control unit 100. In embodiments involving the use of elastic members 294, these elastic members can push back against the control unit 100 and help to slide the cartridge assembly 200 away from the control unit 100.

[0187] The control unit 100 may include, for example, a computing device including a processor and a memory, where the computing device may be configured to receive instructions or signals from the user interface 102 and process these instructions or signals to output one or more commands or control signals. For example, a control signal can be sent from the computing device to one or more motors contained within the control unit 100, which are configured to actuate one or more dispensing mechanisms 300 within the cartridge assembly 200 as described above.

[0188] In various embodiments, the control unit 100 (e.g., its computing device) may be configured to detect full docking of the cartridge assembly 200 with the control unit 100. The control unit 100 may be configured to actuate one or more dispensing mechanisms 300 within the cartridge assembly 200 only when the cartridge assembly 200 is fully docked therewith. For example, once the cartridge assembly 200 is fully docked, the computing device may send control signals only to operate one or more motors included within the control unit 100.

[0189] In various embodiments, the cartridge assembly 200 may include a memory chip that the control unit 100 (e.g., its computing device) may detect and read when docked. The memory chip on the cartridge assembly 200 may contain information about the cartridge assembly 200, such as the type and quantity of the drug contained within the cartridge assembly 200. Additionally or alternatively, the memory chip may contain a specific identifier for that particular cartridge assembly 200. The control unit 100 may detect that a particular cartridge assembly 200 has been docked therewith and pair with that cartridge assembly 200 from that point forward such that the control unit 100 does not work with other cartridge assemblies. This may prevent the cartridge assemblies from switching between control units, effectively forming a digital security seal.

[0190] Figure 14 Shown is similar to Figure 1 the device 10 shown and described above, where like elements are denoted by like reference numerals, but the sliding cover 200 of this embodiment is replaced by a cap or lid 600 that is removable (e.g., fully detachable) from the remainder of the device 10.

[0191] The device 10 includes a control unit 100 that may include any of the features mentioned above with respect to the previous embodiments, including for example a display 104 and an input device or user interface 102. The device 10 also includes a cartridge assembly 200 configured to mate with the control unit 100 in the same manner as in the foregoing embodiments, the cartridge assembly including the various actuation and dispensing mechanisms 300 described above. Instead of having a sliding lid 204 that forms the outer surface of the device 10, in this embodiment, the cartridge 202 itself is configured to mate with the control unit 100 such that the outer surface of the cartridge is placed flush with the outer surface of the control unit 100, as Figure 14 shown.

[0192] Figure 15A disassembled view of the device 10 is shown, where the cartridge 202 and the cap 600 are separated from the control unit 100. To connect the cartridge 202 to the control unit 100, the cartridge can be slid into the control unit 100 in a similar manner as described above with respect to the foregoing embodiments. As in the previous embodiments, the control unit 100 includes a track 116, and the cartridge 202 includes a track 245 (e.g., instead of the guiding cavity 244) that slides onto the track 116, where the cartridge 202 is held in place by the cooperating tracks 116, 245. One or more latches 246 can be provided on the cartridge, which are configured to latch onto a cooperating feature (not shown) on the control unit 100 when the cartridge 202 is fully mated with the control unit 100 to hold the cartridge 202 in place.

[0193] The cap 600 can be removed and / or disassembled from the rest of the device 10, such as the cartridge 202 and / or the control unit 100 (e.g., as Figure 15 shown, completely disassembled). This allows for increased versatility, e.g., the user can reduce the chance of dose spillage and take the dose directly into their mouth. It will be appreciated that a small, lightweight (removable) cap is generally easier to operate than a larger or heavier device, especially when pouring the pellets from the cap into the mouth or into food.

[0194] The cap 600 can be configured to connect to the rest of the device 10 (e.g., the cartridge 202 and / or the control unit 100) by any suitable means (e.g., an interference fit, a magnetic latch, a clip fastener, or a screw connection). The cap 600 can be connected to the rest of the device 10 by a snap fit, e.g., to the cartridge 202 and / or the control unit 100, which provides a convenient way to remove and reattach the cap or lid.

[0195] The cap 600 can include a base 602 and one or more side portions 604 extending from the base 602. The one or more side portions 604 can be configured to connect to the cartridge 202 and / or the control unit 100 to provide a seal (e.g., an airtight seal) between the cap 600 and the rest of the device 10 (e.g., the cartridge 202 and / or the control unit 100). In this way, the cap 600 can form a cup configured to receive the pills dispensed from the cartridge 202 (e.g., its dispensing mechanism 300).

[0196] The device 10 can include a funnel 550, which can be similar to the funnel 500 described above with respect to Figure 13A -C.

[0197] Figure 16 A view of the device 10 is shown where the cap 600 is partially cut away, and a non-limiting method of removing the cap is also indicated, which will be described in more detail below.

[0198] The cap 600 can be configured to connect to the cartridge 202 at its dispensing end 250 so as to cover the dispensing end 250 and create a collection area 630 that is configured to receive and store the drug dispensed from one or more dispensing mechanisms 300 of the cartridge 202. The cap 600 is movable between a first position and a second position (e.g., a disengaged position), in which the collection area 630 forms an enclosed cavity in the first position and the collection area 630 is exposed in the second position, such that a user can access the drug contained therein.

[0199] In various embodiments, and similar to the lid 200, at least a portion of the cap or lid 600 can be made of a transparent or translucent material in various embodiments such that a user can see the drug (e.g., pellets) deposited in the collection area 630 of the cap or lid 600. For example, at least the portion of the cap 600 corresponding to the upper surface and / or the lower surface of the device 10 can be transparent or translucent.

[0200] The funnel 550 can include an inlet end 552 that is configured to be placed on the outlet end of the cartridge 202 and / or the dispensing mechanism 300 to receive the pellets dispensed therefrom. The funnel 550 can further include an outlet end 554 that is at least partially located within the collection area 630. In this way, the funnel 550 can be configured to direct the pellets from the cartridge 202 and into the collection area 630.

[0201] The funnel 550 tapers from the inlet end 552 to the outlet end 554, where the outlet end 554 can be offset or otherwise positioned such that the pellets are directed to a specific portion of the collection area 630. For example, the outlet end 554 of the funnel 550 can be positioned adjacent to and / or cover a specific portion of the collection area 630.

[0202] The outlet end 554 of the funnel 550 can be biased toward a surface 632 of the collection area 630 that can be located on the side of the cap 600 corresponding to the lower surface 14 of the device 10 and / or can correspond to a side portion 604 of the cap 600 that itself forms a part of the lower surface 14 of the device 10. The specific portion can be a corner of the cap 600, a central region of the cap 600, or any other suitable portion, as will be described in more detail below.

[0203] The funnel 550 can be configured such that the pellets are directed to the bottom corner of the cap 600 (where the bottom corner includes the aforementioned surface 632) that is on the same side as the lower surface 14 of the device 10. That is, the outlet end 554 of the funnel 550 can be positioned adjacent to and / or cover that corner or surface 632 on the cap 600.

[0204] The funnel 550 can be configured to allow for the directional removal of the cap 600 such that the user is directed to remove the cap 600 in a certain direction. For example, and as Figure 16 shown, the funnel 550 can include a lower surface 556 that is substantially parallel to and positioned in close proximity to an adjacent side portion 604 of the cap 600. The funnel 550 can further include an upper surface 558 that is opposite the lower surface 556, wherein the upper surface 558 tapers away from the adjacent side portion 604 of the cap 600.

[0205] Accordingly, there will be a relatively small gap G1 between the outlet end 554 of the funnel 550 and the corresponding side portion 604 of the cap 600 on one side (in this case, the lower surface 14 of the device 10), and a relatively large gap G2 between the outlet end 554 of the funnel 550 and the corresponding side portion 604 of the cap 600 on the other opposite side (in this case, the upper surface 12 of the device 10).

[0206] As a result, since the larger gap G2 means that it is easier to rotate the cap 600 in that direction, the user will be directed to remove the cap 600 in the direction indicated by the dashed line in Figure 14 shown. For example, if the user attempts to rotate the cap 600 in the other direction, the side portion 604 of the cap 600 will very quickly meet the lower surface 556 of the funnel 550 and present an obstacle, which makes it more difficult.

[0207] The above features can be combined to reduce the chance that pellets dispensed into the collection area 630 are lost (e.g., spill out) when the cap 600 is removed. In an Figures 14 - 16 embodiment, for example, the funnel 550 is configured to direct the pellets to a corner portion of the cap 600, and additionally, the user is instructed to remove the cap 600 in a downward motion, which means that this corner of the cap 600 is not inverted or moved upward, which could cause the loss of pellets during the process.

[0208] The cap 600 can be further optimized to facilitate the pouring out of pellets therefrom and can have certain features in various embodiments that assist in this action as described below.

[0209] Figure 17An embodiment of a cap 600 is shown that includes a plurality of features that facilitate the targeted pouring of pellets; the cap 600 may include a lower surface 604a corresponding to the lower surface 14 of the device 10. The lower surface 604a may be located on the side of the respective side portion 604 opposite the surface 632 described above. In various embodiments, the lower surface 604a may be curved such that the side portion 604 of the cap 600 corresponding to the lower surface 604a is convex, for example, protruding in a direction away from the interior and / or collection area 630 of the cap 600. This provides a first pouring lip 606a of the cap 600 that facilitates the user in pouring pellets from the cap 600, as shown by arrow 1.

[0210] The cap 600 may include corner portions 604b on the side portion 604 of the cap 600 corresponding to the upper surface 12 of the device 10. These corner portions 604b may provide separate (but identical) pouring lips 606b of the cap 600 that are opposite the pouring lip 606a formed with the lower surface 604a. Since the pouring lips 606b involve the sharp corners of the cap 600, they may be used for more targeted pellet pouring compared to the wider pouring lip 606a, as shown by arrow 2.

[0211] Other arrangements are envisioned in which one or more pouring lips are provided on the cap by manipulating one or more side portions 604 of the cap 600. As will be understood by those skilled in the art, any suitable shape of the side portion 604 may be used.

[0212] As Figure 16 and 17 (and subsequent figures) show, the curved characteristics of the cap 600 can help provide an automatic righting function. In various embodiments, the cap 600 includes a flat base 602 that is configured such that it can remain stationary when the cap 600 is positioned on a flat base. In addition to this, the cap 600 may include curved side portions 604a that extend from the base 602 to the upper edge 608 of the cap 600. The flat base 602 allows the cap 600 to be stable when placed on a table, while the curved rear side portions 604a of the cap that extend from the base 602 to the edge 608 serve to ensure that the cap is always placed vertically on the table regardless of the angle at which the user drops it (unless placed face down on a substantially flat side portion). When the user removes the cap, they can place the cap on any part of the curved back, and the cap will automatically right itself without spilling the pellets. The weight of the pellets in the collection area can be used to assist this automatic righting feature and / or the base 602 itself can be weighted to assist this function (although this is not necessary).

[0213] Figure 18 and Figure 19An embodiment of the cap 600 is shown, which includes one or more inserts or solid portions 620 configured to direct the pellets into a particular portion 640 of the cap 600 and / or the collection area 630. In various embodiments, the funnel 550 as described above may be used, wherein the outlet end 554 is positioned such that the pellets are primarily directed into a particular portion 640 of the collection area 630. For example, the outlet end 554 of the funnel 550 may be positioned adjacent to and / or cover a particular portion 640 of the collection area 630. The outlet end 554 of the funnel 550 may be biased towards a particular portion 640 of the collection area 630.

[0214] The particular portion 640 may correspond to an area or portion of the cap 600 where the pellets are configured to converge or accumulate when they fall into the cap 600 (e.g., when it is vertical). One or more surfaces (e.g., the conical surface 622) of the insert or solid portion 620 may lead to the particular portion 640.

[0215] Various suitable geometries may be used in combination with one or more inserts or solid portions 620, which may depend on the size of the pellets and the desired pouring characteristics (e.g., for different users). One or more inserts 620 may be provided in modular form such that the user or manufacturer can select from a plurality of different inserts that provide the most practical pouring technique for all users. In various embodiments, the steepness of one or more surfaces of one or more inserts or solid portions 620 may be varied or customized for specific requirements. Additionally, or alternatively, the position of the particular portion 640, the curvature of one or more surfaces (e.g., the conical surface 622), the height or thickness of the insert or solid portion 620 may be changed.

[0216] In various embodiments, one or more inserts or solid portions 620 may include one or more of a profile, protrusion, bulge, ridge, cavity, relief, etc., which may be configured to direct or guide the pellets to the particular portion 640.

[0217] In Figure 18 the embodiment, the insert 620 includes a conical surface 622a that forms a bowl leading from the outer perimeter of the cap 600 to the particular portion 640, which in this case may be provided as a cylindrical cavity at the bottom of the cap 600 (although it may simply be formed by the bottom of the bowl). In use, when the pellets are dispensed into the cap 600, they will be directed into the collection area 630 and then, if necessary, they will fall onto the conical surface 622a and be directed into the particular portion 640.

[0218] In Figure 19In an embodiment, the insert 620 also includes a tapered surface 622b. Although in this case the tapered surface 622b forms an inclined or sliding member that extends from the outer periphery of the cap 600 on one side thereof and downward to a specific portion 640 of the cap 600 on its opposite side, it is also located at the bottom of the cap 600. Thus, in use, when the pellets are dispensed into the cap 600, they will be guided into the collection area 630, and then, when necessary, they will fall onto the tapered surface 622b and be guided into the specific portion 640.

[0219] Of course, many other insert arrangements are envisioned, which can be configured to guide the pellets to a specific portion similar to that described with respect to Figure 18 and 19 the described embodiments. As shown with respect to those embodiments, these will generally include some kind of tapered surface that leads from the outer periphery of the cap 600 to the specific portion 640. Using the inserts described herein can help collect a certain dose of pellets (e.g., a relatively small dose) into a more concentrated area. This can improve the visibility of the pellets for the user, such that they can then more easily guide the pellets into their mouth or elsewhere.

[0220] It is further envisioned that during the process of pouring the pellets from the cap 600, an insert or a solid portion can be used to create a funneling effect. For example, the insert or solid portion of the cap 600 can be shaped to guide the pellets contained within the collection area 630 to one or more pouring lips, such as the pouring lips 606a, 606b described above. One skilled in the art can envision how to construct the insert or solid portion in this manner, for example, the insert or solid portion can provide a channel or valley for the pellets to travel from the collection area to one or more pouring lips.

[0221] Figure 20A and 20B shows an embodiment of the cap 600 that includes a solid portion or insert 620 that includes a tapered surface 622c similar to the Figure 19 tapered surface 622b, except that it is steeper and extends from a portion of the upper edge 608 (which may correspond to the pouring lip 606a described above) and slopes downward to an opposite side portion 604 that extends between two corner portions 604b. The tapered surface 622c can meet the opposite side portion 604 approximately halfway along the height of the side portion 604, as shown at 608b.

[0222] In this embodiment, the cap 600 further includes a cavity 650 located within the insert 620 and the conical surface 622c such that it forms a recess in the conical surface 622c towards the bottom 602 of the cap 600. The cavity 650 is shaped to form a collection area 630 at its bottom 654, wherein the conical surface 622b is configured to direct the pellets into the cavity 650 when dispensing the pellets into the cap 600. The size of the cavity 650 itself increases as it moves from the top of the cap 600 (e.g., the edge 608) towards the bottom 602 of the cap 600, and the cavity 650 itself includes an inclined surface 652 that is configured to direct the pellets towards the bottom 654 of the cap 600 once the pellets enter the cavity 650, for example, from the conical surface 622b.

[0223] The features of this embodiment mean that, as Figure 20B shown, the cap 600 can be inverted such that the cavity 650 itself becomes a pouring lip and the inclined surface 652 of the cavity 650 forms a slide that directs the pellets out of the cap 600, as indicated by arrow 3.

[0224] The insert or solid portion (e.g., Figure 19 the insert 620 as shown therein) can be configured to direct the pellets towards the front of the cap 600, e.g., the portion of the cap that is positioned towards or forms part of the upper surface 12 of the device 10 (e.g., the side portion 604). This can help the user see that a dose has been dispensed as the pellets will be located closer to them once dispensed.

[0225] Figure 21 A side view of the device 10 is shown, which includes the cap 600 when fully assembled, and shows the cartridge assembly 200 connected to the control unit 100, and the cap 600 placed on both the control unit 100 and the cartridge assembly 200 to form a receiving area 630 in the form of an enclosed cavity within the cap 600 as described above.

[0226] Figure 21A A cross-section of the lower end of the device 10 in its assembled state is shown, and shows a funnel 550 that directs the pellets from the dispensing mechanism 300 of the cartridge assembly 200 into the collection area 630 of the cap 600. The dispensing mechanism 300 includes a screw pump 304 as described above, which is configured to convey the pellets from within the cartridge assembly 200 to its outlet 302. The funnel 550 includes an outlet end 554 as described above, which has a hole 555 that is adjacent to a surface 632 that is located on the side of the cap 600 corresponding to the lower surface 14 of the device 10, and / or can correspond to the side portion 604 of the cap 600 that itself forms part of the lower surface 14 of the device 10.

[0227] As described above with regard to Figure 16As described, the main removal direction of the cap 600 can provide a simple mechanism for using the cap, which can be understood by studying Figure 21 and 21A to understand.

[0228] A rolling pivot can be provided between the cap 600 and the funnel 550. For example, the funnel 550 can include a curved surface 559, and the cap 600 can be configured to roll on the curved surface 559 when it is removed (e.g., in the main direction of removal described above). In the illustrated embodiment, the upper surface 558 of the funnel 550 includes a curved portion 559 adjacent to the opposing inner surface 609 of the cap 600. When the cap 600 is removed, its inner surface 609 is configured to roll on and / or over the curved portion 559 of the funnel 550, which can create a ramp to gently rotate the cap 600 to the open position. Using a rotating pivot or a curved surface can reduce the chance of opening that could cause pellets to be lost due to spillage.

[0229] It should also be noted that the funnel 550 can assist in the replacement of the cap 600 by ensuring that the cap 600 is properly aligned with the rest of the device 10 when attached thereto.

[0230] Figure 22 and 22A An embodiment of the cap 600 is shown that is similar to the cap described above, but includes a tactile region 660 as part of or on its outer surface. In the illustrated embodiment, on one of the side portions 604 of the cap 600, particularly on the side portion 604 that forms part of the upper surface 12 of the device 10, the tactile region 660 is provided as a textured surface that corresponds to the side portion 604 extending between two corner portions 604b. As Figure 22A shown, the tactile region 660 can be formed by a plurality of cavities 662, but any suitable texture that provides a tactile sensation to the user can be provided. For example, the tactile region 660 can be provided by protrusions or depressions.

[0231] The tactile region 660 can be used to improve the user's grip when manipulating the cap 600, e.g., as shown and described above, e.g., with respect to Figure 16 . The tactile region 660 can also provide a visual cue to the user, e.g., to indicate that they should interact with that part of the device 10 to remove the cap 600 as described above. Finally, using the tactile region 660 can improve the device 10's ability to withstand wear during use, e.g., to mask scratches or scuffs.

[0232] As shown in the illustrated embodiment, the tactile region 660 can be applied only to the side portion 604 of the cap 600 that forms part of the upper surface 12 of the device 10. This can help indicate to the user that they should push on that area of the cap 600 to, e.g., as described above with respect to Figure 16Remove the cap 600 as described.

[0233] Figure 23 and 23A illustrates Figure 22 and 22A minor variations of the illustrated embodiments, where the cap 600 includes a haptic region 660 only on approximately half of the side portion 604 that forms part of the upper surface 12 of the device 10. More specifically, the haptic region 660 may be located near the upper edge 608 and may extend only approximately half along the side portion 604 from the upper edge 608. This may provide a more specific indication to the user of where to push the cap 600 in order to remove it.

[0234] These embodiments may be combined with embodiments where the cap 600 (or at least the side portion 604 that forms part of the upper surface 12 of the device 10) is made transparent or translucent. In this case, positioning the haptic region 660 in this part of the cap 600 would mean that the user could easily view the drug (e.g., pill) dispensed into the collection area 630 of the cap 600. This is indicated by Figure 23 the arrow 664 in.

[0235] Figure 24 and 24A illustrates Figure 22 and 22A further variations of the illustrated embodiments, where the cap 600 includes a haptic region 660 on the side portion 604 of the cap 600 that forms part of the lower surface 14 of the device 10. The side portion 604 of the cap 600 that forms part of the upper surface 12 of the device 10 may be flat, for example, remaining without any surface variations. By providing the haptic region 660 on this part of the cap 600, the user can still achieve an improved grip on the cap 600, but the upper surface 12 of the device 10 will be more visually appealing.

[0236] Additionally, when combined with embodiments where the cap 600 (or at least the side portion 604 that forms part of the upper surface 12 of the device 10) is transparent or translucent, positioning the haptic region 660 in this part of the cap 600 would mean that the user could very easily view the drug (e.g., pill) dispensed into the collection area 630 of the cap 600. This is indicated by Figure 23 the arrow 666 in.

[0237] For Figure 22A , 23A and the textures shown in 24A, alternatively or additionally, the haptic surface 660 may include ridges or stripes 663 on the outer surface of the cap 600, which may serve any of the purposes described above for the haptic surface 660 in the form of the cavity surface 662. In Figure 25A horizontal ridge 663 (e.g., parallel to the upper edge 608 of the cap 600) is shown in, while a vertical ridge 663 (e.g., perpendicular to the upper edge 608 of the cap 600) is shown in. The horizontal ridges can provide improved grip as they will more easily allow the user to remove the cap 600 as described above. Given the aspect ratio of the device 10 as a whole, the vertical ridges may be easier to manufacture (e.g., by injection molding) and more visually appealing. Figure 26 A vertical ridge 663 (e.g., perpendicular to the upper edge 608 of the cap 600) is shown in. The horizontal ridges can provide improved grip as they will more easily allow the user to remove the cap 600 as described above. Given the aspect ratio of the device 10 as a whole, the vertical ridges may be easier to manufacture (e.g., by injection molding) and more visually appealing.

[0238] Figure 27A and 27B show minor variations on the funnel 550 shown in Figure 21A . Figure 27A and 27B The funnel 550 of and may include an inlet end 552 configured to be placed on the outlet end of the cartridge 202 and / or the dispensing mechanism 300 to receive the pellets dispensed therefrom. The funnel 550 also includes a modified outlet end 554' that may be at least partially positioned within the collection area 630 of the cap 600. Like the funnel 550 shown in Figure 21A , the funnel 550 of this embodiment may be configured to direct the pills from the cartridge 202 into the collection area 630. In this embodiment, the outlet end 554' is fully open, thus providing a relatively large aperture 555' for directing the pellets from the cartridge 202 into the collection area 630.

[0239] The funnel 550 described herein may be modified to provide a controlled settlement of the pellets from the cartridge 202 into the collection area 630. For example, one or more screens may extend across the outlet end 554 (or 554') of the funnel 550, where the one or more screens may be configured to capture the pellets dispensed from the cartridge 202 and temporarily trap them before dispensing them into the collection area 630.

[0240] Figure 28 shows an embodiment of a funnel 550 incorporating a screen in the form of a grille 570, the grille including a plurality of bars 572 that capture the pellets dispensed from the dispensing mechanism of the cartridge 202 and then temporarily trap the pellets before further dispensing them from the funnel 550 into the collection area 630. That is, the pellets will fall out of the cartridge 202 and be trapped or caught (e.g., slowed down) between two of the bars 572 before moving through and past the bars 572 into the collection area 630. The distance between the bars 572 (e.g., the minimum distance) may be slightly greater than the diameter of the pellets.

[0241] As Figure 28As shown, the bar 572 can be teardrop-shaped, where, in use, the sharp edge of the teardrop faces the dispensing mechanism of the cartridge 202. This can help the grate 570 perform its function of capturing the pellets dispensed from the dispensing mechanism for forward transmission through the grate 570 (arrow 574), while inhibiting the pellets from re-entering the funnel 550 (arrow 576).

[0242] Providing a screen as described above, and in particular providing a grate 570 as Figure 28 shown, can help protect the dispensing mechanism of the cartridge 202 from tampering (by reducing the user's ability to access the interior of the funnel 550). Additionally, especially when combined with the improved fully open exit end 554', a large area is provided for the pellets to fall when dispensed, while providing a mechanism for controlling the dispensing of the pellets.

[0243] One or more screens can be configured such that the pellets are more likely to fall through the screen in a first dispensing direction (see arrow 574 in Figure 28 ), and less likely to fall through the screen in a second non-dispensing direction (see arrow 576 in Figure 28 ).

[0244] As Figure 29A -D shows, one or more screens can be provided in any suitable form, where Figure 29A the funnel 550 is shown separately, and the bar 572 is schematically shown, which can extend vertically from one side of the exit end 554 to the other side. Figure 28 The funnel 550 is shown, which includes a screen located above the exit end 554 of the funnel 550 and includes a plurality of holes 580, where the diameter of the holes 580 can be slightly larger than the diameter of the pellets accommodated in the cartridge 202 and dispensed from the dispensing mechanism.

[0245] Figure 29B The funnel 550 is shown, which includes a screen located above the exit end 554 of the funnel 550 and includes a grate 570' similar to

[0246] Figure 29C a grate, except that the bar 572' of the grate 570' extends horizontally across the exit end 554. Figure 29A The funnel 550 is shown, which includes a screen located above the exit end 554 of the funnel 550 and includes a grate 570' similar to

[0247] Figure 29D a grate, except that the bar 572' of the grate 570' extends horizontally across the exit end 554. Figure 21A The funnel 550 is shown, which incorporates a simple hole that can be similar to the hole 555 as

[0248] Figure 30 shown, where the hole 555 can be in the form of a curved slit, and the transverse width (i.e., transverse to the longitudinal axis of the slit) is slightly larger than the diameter of the pellets accommodated in the cartridge 202. 30Ashows an embodiment similar to the embodiment discussed above with respect to Figures 9 to 11 but having a slightly different mechanism for operating the dispensing mechanism of the cartridge 202. That is, the cartridge assembly 200 and the control unit 100 are interconnected by a splined connection instead of the male and female connecting elements 180, 280.

[0249] As described above, the cartridge assembly 200 and the control unit 100 are configured to engage with each other to allow the control unit 100 to operate the cartridge mechanism to dispense the drug contained in the cartridge 202. This engagement can be initiated by inserting the cartridge assembly 200 into the first portion 110 of the control unit 100 (see Figure 2 ) such that the cartridge 202 engages with the control unit 100 using, for example, the cooperating tracks 245, 116 as described above and allows the cartridge assembly 202 to slide along the planar portion 112 towards the interface 130 of the control unit 100.

[0250] In the Figure 30 and Figure 30A embodiments, the interface 130 of the control unit 100 includes a drive element (not shown) that is configured to drive (e.g., rotate) a cooperating receiving element 712, each receiving element being connected to a respective dispensing mechanism 300 of the cartridge 202.

[0251] Figure 30A The receiving element 712 is shown in more detail, where the drive element (not shown) can include spline teeth configured to engage with mating spline teeth 714 located on the receiving element 712. In this way, rotation of the drive element causes corresponding rotation of the receiving element 712 and ultimately actuates the respective dispensing mechanism 300. Thus, when the drive element rotates, one or more drugs in the form of pellets, for example, are dispensed from the cartridge 202. This can provide a somewhat simpler alternative to the male and female connecting elements 180, 280 described above.

[0252] Figure 30 and Figure 30A also shows an alternative type of locking arrangement and locking plate 290 with respect to the embodiment described above with respect to Figures 8 to 11 .

[0253] That is, the locking member can consist of a first ring 720, a second ring 722, and one or more connecting elements 724. The locking member including the first ring 720, the second ring 722, and the connecting element 724 is fixed, for example, by using tabs 726 that engage with non-rotating portions of the device 10 to prevent rotation.

[0254] The locking member can surround each receiving element 712 and is configurable to lock the spline teeth 714 of the receiving element 712 against rotation when the cartridge 202 is not engaged with the control unit 100. When the cartridge 202 is engaged with the control unit 100, a portion of each locking member is configured to move (discussed in more detail below) to allow the receiving element 712 to rotate and allow actuation of the corresponding dispensing mechanism 300.

[0255] Figure 31A and 31B The mechanism is shown in more detail.

[0256] The receiving element 712 is shown as forming the end of the shaft 304 of the dispensing mechanism 300 as described above. Thus, rotation of the receiving element 712 causes rotation of the shaft 304 and, in turn, actuation of the dispensing mechanism 300 associated with the shaft 304. A first ring 720 of the locking member initially surrounds the receiving element 712, particularly a radially extending surface of the receiving element, wherein the first ring 720 includes teeth 721 configured to selectively engage the radially extending surface of the receiving element 712.

[0257] In this embodiment, the radially extending surface is conveniently the radially extending surface of the spline teeth 714 of the receiving element 712. It has been found that this simplifies the number of parts required to provide a locking feature for the rotating element (i.e., the shaft 304) of the dispensing mechanism 300 of the cartridge 202.

[0258] A second ring 722 of the locking member is connected to the first ring 720, and the first ring 720 is connected to the second ring 722 by one or more elastic connection elements 724 configured to deform in the direction of arrow 3 when pressure applied to the first ring 720 is applied in the same direction.

[0259] The first ring 720 is slidably received on the outer surface of the shaft 304 such that the first ring 720 can slide between a first position as Figure 23A shown and a second position as Figure 23 shown in B.

[0260] In the first position, the teeth 721 of the first ring 720 engage the spline teeth 714 of the receiving element 712 to prevent rotation of the shaft 304. In the second position, the first ring 720 has moved in the direction of arrow 3 along the axis of the shaft 304 such that the teeth 721 of the first ring 720 are now disengaged from the spline teeth 714 of the receiving element 712, thereby allowing rotation of the shaft 304.

[0261] The elastic connection element 724 allows the first ring 720 to slide. The sliding movement itself can be caused by the engagement of the first ring 720 with one or more elements 132 of the interface 130 on the control unit 100. These elements 132 can be in the form of pins, for example similar to Figure 10A the pin 184 shown in

[0262] Figure 32A and 32B show a slight modification to the Figures 30 to 3 locking member shown in FIG. 1, in which a single locking member 800 is provided, which is configured to prevent actuation of a plurality of dispensing mechanisms in a first position and to allow actuation of the dispensing mechanisms in a different second position.

[0263] The combined locking member 800 is used to lock Figure 30 the two receiving elements 712 shown simultaneously. The locking member 800 can consist of two rings 820 with locking teeth 821 and a single elastic element (e.g., a spring) 824.

[0264] The locking member 800 (in particular its rings 820) can surround each receiving element 712 and is configurable to lock the spline teeth 714 of the receiving element 712 against rotation when the cartridge 202 is not engaged with the control unit 100. When the cartridge 202 is engaged with the control unit 100, a portion of the locking member is configured to move (discussed in more detail below) to allow the receiving element 712 to rotate and allow actuation of the corresponding dispensing mechanism 300.

[0265] The rings 820 of the locking member initially surround the corresponding receiving elements 712 and, in particular, the radially extending surface of the receiving element (e.g., the radially extending surface of the spline teeth 714), where each ring 820 includes teeth 821 that are configured to selectively engage the radially extending surface of the receiving element 712.

[0266] The locking member 800 includes a single elastic member (e.g., a spring) 824 of the locking member, which is connected to the two rings 820 and is configured to deform when pressure is applied to the first ring 820. The elastic member 824 can be configured to become biased against a portion of the control unit 100 when the locking member 800 moves between its first and second positions.

[0267] The rings 820 are slidably received on the outer surface of the shaft 304 such that the rings 820 can move in a manner similar to Figure 30A 、 31Aslide between the first and second positions in a manner similar to loop 720 of 31B (i.e., in the direction of arrow 3).

[0268] In the first position, the teeth 821 of loop 820 engage with the spline teeth 714 of the receiving element 712 to prevent rotation of the shaft 304. In the second position, loop 820 has moved along the axis of the shaft 304 (e.g., in the direction of arrow 3), so that the teeth 821 of loop 820 are now disengaged from the spline teeth 714 of the receiving element 712 to allow rotation of the shaft 304.

[0269] The elastic member 724 allows the sliding movement of loop 820. The sliding movement itself can be caused by the engagement of loop 820 with one or more elements 132 of the interface 130 on the control unit 100. These elements 132 can be in the form of pins, for example similar to Figure 10A the pin 184 shown in. The elastic member 824 can bias loop 820 in a direction opposite to arrow 3, such that they bias loop 820 against the elements 132 of the interface 130 on the control unit 100.

[0270] In this way, the combined locking member 820 beneficially includes a locking loop 820 having a common elastic member. The loop 820 can be pushed back by the control unit 100 during docking of the cartridge 200 to the control unit 100 in a manner similar to the loop 720 of the previous embodiment. When the cartridge 200 is removed from the control unit 100, the combined locking member 820 can snap back and re-engage the lock to prevent actuation of the dispensing mechanism.

[0271] Like the locking member 720 described previously, the locking member 800 including loop 820 is fixed against rotation, for example using one or more tabs 826 that engage non-rotating portions of the engagement device 10.

[0272] Generally, the devices disclosed herein can be intended to provide an accurate dose of a drug by weight and also provide a simple mechanism by which the dose and / or titration of the drug can be adjusted during use. Various mechanical features are provided to facilitate dosing, including swallowing the dose and providing general convenience in doing so. Various embodiments are also intended to monitor compliance.

[0273] The handheld device 10 can combine medical knowledge with digital capabilities. The control unit 100 can be reusable and can be combined with various different cartridge assemblies 200 preloaded with prescription drugs. For example, for ADHD, the cartridge assembly 200 can be prefilled with the relevant drugs for use over a one-month period. The cartridge 202 can be filled with pellets or granules (i.e., oral dosage forms) each having a size less than 1000 nm. These granules can be taken with a liquid or soft food that supports drug swallowing. The digitalization of the control unit 100 enables precise dose setting and titration. Although the device has a specific use for ADHD, the technology disclosed herein is applicable to many other treatments, especially for pediatric use or for the treatment of psychiatric, neurological, cardiometabolic disorders, or oral cancer.

[0274] Exemplary treatments that can be related to the devices described herein are attention deficit hyperactivity disorder (“ADHD” - where the drugs used in the device can include amphetamines and / or methylphenidate), systemic pain (where the drugs can include one or more of fentanyl, methadone, meperidine, tramadol, morphine, codeine, thebaine, oxymorphone, hydrocodone, oxycodone, hydromorphone, naltrexone, buprenorphine, and methadone), immunosuppression after organ transplantation (where the drugs can include one or more of tacrolimus, sirolimus, everolimus, corticosteroids, cyclosporine, mycophenolate mofetil, and azathioprine), diabetes (where the drugs can include one or more of sitagliptin, vildagliptin, saxagliptin, linagliptin, metformin, canagliflozin, dapagliflozin, empagliflozin, and semaglutide), heart failure (where the drugs can include one or more of carvedilol, metoprolol, bisoprolol, and diuretics), Parkinson's disease (“PD” - where the drugs may include levodopa and / or carbidopa), epilepsy (where the drugs can include one or more of sodium valproate, sodium carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, etosimide, and topiramate), depression (where the drugs can include one or more of citalopram, bupropion, paroxetine, milnacipran, fluoxetine, duloxetine, fluvoxamine, and reboxetine), schizophrenia (where the drugs can include one or more of aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, and olanzapine), cancer, animal health. For example, the device 10 can be combined with drugs (e.g., in the form of pellets) directed at or related to the above treatments, such as any or all of the above treatments.

[0275] The various embodiments disclosed herein are directed to improving the manner in which the user is prompted to dispense the drug from the device 10 into a receptacle, liquid or soft food, or into their mouth. For example, as described above with respect to Figure 16As described, the cap 600 can be configured such that it prompts the user to remove the cap 600 in a predetermined direction during operation.

[0276] The device 10 disclosed herein can provide simpler dose setting and accurate dose titration, especially for children. Using drugs formulated as pellets or granules can support accurate dose adjustment and help with swallowing problems in pediatric patients. The development of pediatric drugs typically involves different formulations or devices that address one or both of the challenges faced by this patient population. By combining a digitally enabled drug with the handheld device 10 disclosed herein, improvements in dose setting, titration, ease of use, swallowability, and compliance are achieved. The technology can be tailored to different treatment regimens for the pediatric population, including combination therapies. Other areas of treatment using the device 10 disclosed herein can be epilepsy and general pain relief. Dispensing techniques can also be developed for infectious diseases in children, for example, the drugs used with the device (e.g., in the form of pellets) can include amoxicillin and / or penicillin.

[0277] The control unit 100 (in any aspect or embodiment described herein) can include an input device or user interface 102, which can include one or more buttons for operating the device 10, such as the dispensing mechanism 300 therein. The control unit 100 can include means for ensuring that only the correct or specific user or user type can manipulate and / or operate the device. For example, the control unit 100 can incorporate a fingerprint sensor or password technology configured to detect the fingerprint of the user.

[0278] The control unit 100 can include a control system configured to operate the various electrical and mechanical parts of the device 10, such as the user interface 102, the display 104, and the dispensing mechanism 300.

[0279] The control system can be configured to improve the method of administering oral drugs through the various features of the device 10 described herein. Digitizing drugs using the techniques described herein can have several advantages compared to providing conventional pills, for example, in a bottle. The preloaded cartridge 202 (e.g., for ADHD, with a one-month prescription) can have an integrated circuit board run that conveys relevant information to the control unit. The control unit 100, particularly its control system, can set the dose, prevent taking more than the maximum dose, allow titration, and ensure notification of tampering. The control system can record the dispensing of the drug, for example, over a defined period (e.g., a one-month prescription).

[0280] The control system can be configured to provide, for example, a dosage reminder on the display 104 of the control unit 100, as well as a log of previously taken dosages. It is contemplated that further personalization can be achieved by providing a wireless connection to an external device such as a smart phone, smart watch or other smart device, sensor or wearable device. The wireless connection can use Bluetooth or any other suitable wireless platform. The control system can be integrated with an application on a smart phone, smart watch or other smart device, or can be at least partially executed on such a device.

[0281] The control system can be configured to receive symptom reports from the user and record these symptom reports in relation to the administered medication. For example, for ADHD, symptoms can include attention span, hyperactivity, behavior, productivity, etc., which can all support the treatment plan and other outcomes.

[0282] The control system can be integrated with or at least partially implemented on an application for a caregiver. For example, the control system can be configured to send reports, such as wirelessly and / or over the Internet, to such an application. The report can include compliance data, e.g., whether the user has been taking the dosages as per the treatment plan. The report can include data or information regarding the dosages taken, the administration times, and the above-mentioned symptoms.

[0283] For example, in combination with at least the control system of the above-mentioned control unit 100, the methods, method steps or functional features disclosed herein can be at least partially implemented using software, e.g., a computer program. These can be located on the data processor of the control unit 100 itself. Thus, it is understood that, in other aspects, the present invention provides computer software that, when installed on a data processing device, is specifically adapted to execute the methods, method steps or functional features described herein; a computer program element comprising a computer software code portion that, when the program element runs on a data processing device, is used to execute the methods, method steps or functional features described herein; and a computer program that contains code for all steps suitable for executing the methods, method steps or functional features described herein when the program runs on a data processing system. The data processor can be a microprocessor system, a programmable FPGA (Field Programmable Gate Array), etc.

[0284] For example, this can be a fingerprint sensor required to activate the device or a code pattern on the display (e.g., up, up, down, right, up, left on the D-pad), so that parents and caregivers can use the device without the need for a specific fingerprint (not having a fingerprint sensor can also reduce costs).

[0285] Although the present invention has been described with reference to preferred embodiments, those skilled in the art will understand that various changes can be made in form and detail without departing from the scope of the invention set forth in the appended claims.

Claims

1. An apparatus (10) for dispensing one or more medicaments in the form of pellets, comprising: a cartridge assembly (200) configured to store medicaments in the form of pellets and to dispense the medicaments when actuating one or more dispensing mechanisms (300) located within said cartridge assembly (200); a control unit (100) comprising one or more actuators, configured to actuate said one or more dispensing mechanisms (300) located within said cartridge assembly (200), wherein each of said one or more dispensing mechanisms (300) comprises one or more rotatable elements (304), and rotation of said one or more rotatable elements (304) causes the medicaments to move from a respective one of the respective storage cavities within said cartridge assembly (200) to a collection area (230) of a lid (204), wherein said lid (204) is movable between a first position and a second position, in the first position, the collection area (230) of said lid (204) forms a closed cavity such that when the lid is in its first position, the medicaments received in the collection area cannot escape therefrom, and in the second position, said lid (204) is separated from the remainder of the apparatus (10) and exposes the collection area (230) so that a user can access the medicaments contained therein, wherein said cartridge assembly (200) comprises one or more locking members (290) movable between a first position and a second position, wherein each of said locking members (290) is configured to prevent actuation of the respective dispensing mechanism (300) in the first position and to permit actuation of said dispensing mechanism (300) in the second position, wherein said cartridge assembly (200) is configured to dock with and separate from said control unit (100), and the apparatus (10) is configured such that when said cartridge assembly (200) docks with said control unit (100), each of said locking members (290) moves from its first locked position to its second unlocked position, wherein each of said one or more actuators comprises an electric motor configured to rotate a respective one of said rotatable elements (304), and wherein said cartridge assembly (200) comprises one or more rotatable connection elements (280), each connected to a respective one of said rotatable elements (304) and configured to cooperate with a rotatable connection element (180) on said control unit (100) such that rotation of the connection element (180) on said control unit (100) causes rotation of the connection element (280) on said cartridge assembly (200) to rotate the rotatable element (304) of the dispensing mechanism (300) on said cartridge assembly (200).

2. The apparatus according to claim 1, wherein each of said one or more locking members (290) is configured to prevent rotation of a respective one of said rotatable elements (304) when said locking member (290) occupies its first locked position.

3. The device according to claim 1, wherein each of the locking members (290) comprises one or more pins (284) configured to contact one or more stationary portions of the control unit (100), wherein contact between the pins (284) and the stationary portions causes the locking members (290) to move from their first locked position to their second unlocked position when the cartridge assembly (200) docks with the control unit (100).

4. The device according to any one of claims 1-3, wherein the rotatable element (304) comprises one or more radially extending surfaces (286), and the locking members (290) comprise one or more teeth (292) configured to engage the radially extending surfaces (286) when the locking members (290) occupy their first locked position, and to disengage from the radially extending surfaces (286) when the locking members (290) are in their second unlocked position.

5. The device according to claim 4, wherein the locking members (290) are restricted in rotational movement so as to prevent rotation of the rotatable element (304) when the locking members (290) occupy their first locked position and the teeth (292) engage the radially extending surfaces (286), and to permit rotation of the rotatable element (304) when the locking members (290) occupy their second unlocked position and the teeth (292) disengage from the radially extending surfaces (286).

6. The device according to claim 4, wherein the locking members (290) are biased towards their first locked position by one or more respective elastic members (294) such that the teeth (292) are biased by the elastic members (294) into engagement with the radially extending surfaces (286).

7. The device according to any one of claims 1-3, wherein one of the connecting elements (180, 280) on the cartridge assembly (200) and the control unit (100) comprises a male connector, while the other connecting element (180, 280) on the cartridge assembly (200) and the control unit (100) comprises a mating female connector.

8. The device according to claim 7, wherein the connecting element (180) on the control unit (100) comprises a male connector, and the connecting element (280) on the cartridge assembly (200) comprises a mating female connector.

9. The device according to any one of claims 1-3, wherein the diameter of the medicament in the form of pellets is between 150 μm and 1200 μm.

10. A method of using the device according to any one of claims 1-9, comprising moving the one or more locking members (290) from their first position to their second position to permit actuation of the one or more dispensing mechanisms (300) located within the cartridge assembly (200).

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